Devices › Ventilator, continuous, facility use
Device brand name · Ventilator
Servo Ventilator 900c: medical device reports filed with FDA
167 reports name it, 1996–2005. Manufacturer given most often on reports: Siemens-Elema Life Support Systems Division. Product code CBK.
- 167
- device reports naming the brand
- 0% of all MAUDE reports · about 6 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 81.4%
- classified as malfunction
- 91.8% across the product code
- 7.2%
- classified as death, as reported
- 12 reports · not verified by FDA
167 medical device reports received by FDA name the brand "Servo Ventilator 900c" (ventilator); the manufacturer given most often on reports is Siemens-Elema Life Support Systems Division; received from September 1996 to November 2005. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (81.4%), injury (10.2%) and death (7.2%); across all ventilator, continuous, facility use reports (product code CBK) death is recorded in 1.1% and malfunction in 91.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are replace (7.8%), break (7.2%) and defective component (7.2%). The patient problems coded most often are death, manual ventilation required and therapy/non-surgical treatment, aborted/stopped. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Servo Ventilator 900c was received in the five years to August 2026; the latest was received in November 2005.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 213,387 reports carrying product code CBK. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Replace | 13 | 7.8% | 1.2% |
| Breakthe device broke | 12 | 7.2% | 0.6% |
| Defective component | 12 | 7.2% | 2.1% |
| Disconnection | 8 | 4.8% | 0.4% |
| Failure to deliverthe device did not deliver the dose or item | 8 | 4.8% | 1.2% |
| Other (for use when an appropriate device code cannot be identified) | 8 | 4.8% | 0.2% |
| Tidal volume fluctuations | 7 | 4.2% | 0.5% |
| Device alarm system | 6 | 3.6% | 1.8% |
| Failure to cycle | 6 | 3.6% | 3.6% |
| Alarm, audible | 5 | 3% | 0.8% |
| Device issuea problem with the device | 5 | 3% | 0.4% |
| Loss of powerthe device lost power | 5 | 3% | 1.5% |
| Decrease in pressure | 4 | 2.4% | 0.8% |
| Inaccurate delivery | 4 | 2.4% | 0.4% |
| Gas delivery system failure | 3 | 1.8% | 0.1% |
| Motor failure | 3 | 1.8% | 0% |
| Overdelivery | 3 | 1.8% | 0% |
| Component falling | 2 | 1.2% | 0% |
| Component(s), broken | 2 | 1.2% | 0% |
| Failure to calibrate | 2 | 1.2% | 3.3% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 7 | 4.2% |
| Manual ventilation required | 6 | 3.6% |
| Therapy/non-surgical treatment, aborted/stopped | 4 | 2.4% |
| Other (for use when an appropriate patient code cannot be identified) | 3 | 1.8% |
| Respiratory distressdifficulty breathing | 3 | 1.8% |
| Cardiopulmonary arrest | 2 | 1.2% |
| Injurya physical injury | 2 | 1.2% |
| Abnormal blood gases | 1 | 0.6% |
| Apnea | 1 | 0.6% |
| Breathing difficulties | 1 | 0.6% |
| Cardiac arrestthe heart stopped | 1 | 0.6% |
| Decreased peak expiratory flow rate | 1 | 0.6% |
| Disseminated intravascular coagulation (dic) | 1 | 0.6% |
| Hypoxialow oxygen | 1 | 0.6% |
| Low blood pressure/ hypotension | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Servo Ventilator 900c | Product code CBK | All MAUDE reports |
|---|---|---|---|
| Reports | 167 | 213,387 | 26,136,888 |
| Share of that pool | — | 0.1% | 0% |
| Classified as death, per 1,000 reports | 72 | 11 | 9 |
| Classified as injury | 10.2% | 6.8% | 36.2% |
| Classified as malfunction | 81.4% | 91.8% | 62.3% |
| Filed by the manufacturer | 94.6% | 95.9% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code CBK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Trilogy 100 | 31,022 | 2,056 | 0.9% |
| 840 Ventilator | 18,191 | 27 | 0.4% |
| Hamilton Medical Ag | 10,331 | 0 | 0.3% |
| Trilogy Evo | 8,583 | 943 | 1.1% |
| Vela Ventilator | 8,446 | 0 | 0.3% |
| Servo-I | 6,390 | 3 | 1.3% |
| Esprit Ventilator | 6,015 | 0 | 0.4% |
| Vocsn | 5,308 | 854 | 0.4% |
| Trilogy 202 | 5,217 | 74 | 0.3% |
| Carescape R860 | 4,968 | 50 | 0.2% |
| Carescape | 4,902 | 2,289 | 0.1% |
| 980 Ventilator | 4,651 | 117 | 0.2% |
| Trilogy O2 | 4,290 | 48 | 0.3% |
| Avea Ventilator | 3,943 | 0 | 0.5% |
| V200 Ventilator | 3,476 | 0 | 0.2% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Servo Ventilator 900c reports
How many FDA reports name Servo Ventilator 900c?
167 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (81.4%), injury (10.2%) and death (7.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
replace (7.8%), break (7.2%), defective component (7.2%), disconnection (4.8%) and failure to deliver (4.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (94.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Servo Ventilator 900c was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.