Devices › System, balloon, intra-aortic and control
Device brand name · Iabp
System 97e: medical device reports filed with FDA
298 reports name it, 1998–2004. Manufacturer given most often on reports: Datascope. Product code DSP.
- 298
- device reports naming the brand
- 0% of all MAUDE reports · about 11 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 98%
- classified as malfunction
- 89.8% across the product code
- 1.3%
- classified as death, as reported
- 4 reports · not verified by FDA
298 medical device reports received by FDA name the brand "System 97e" (iabp); the manufacturer given most often on reports is Datascope; received from March 1998 to November 2004. 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 (98%) and death (1.3%); across all system, balloon, intra-aortic and control reports (product code DSP) death is recorded in 2.1% and malfunction in 89.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are replace (33.9%), other (for use when an appropriate device code cannot be identified) (18.1%) and leak/splash (15.4%). The patient problems coded most often are therapy/non-surgical treatment, aborted/stopped, therapy/non-surgical treatment/delayed/prolonged and death. 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 System 97e was received in the five years to August 2026; the latest was received in November 2004.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 68,628 reports carrying product code DSP. 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 | 101 | 33.9% | 5.5% |
| Other (for use when an appropriate device code cannot be identified) | 54 | 18.1% | 1.2% |
| Leak/splashthe device leaked | 46 | 15.4% | 5.5% |
| Device displays incorrect message | 26 | 8.7% | 4.5% |
| Device issuea problem with the device | 26 | 8.7% | 0.4% |
| Electrical /electronic property probleman electrical or electronic problem | 20 | 6.7% | 1.4% |
| No display/image | 15 | 5% | 1.8% |
| Failure to power up | 14 | 4.7% | 2.2% |
| Loss of powerthe device lost power | 12 | 4% | 1.1% |
| Failure to pump | 8 | 2.7% | 0.4% |
| Failure, intermittent | 7 | 2.3% | 0.1% |
| Inability to auto-fill | 7 | 2.3% | 4.3% |
| Vacuum, loss of | 6 | 2% | 0.1% |
| Air leak | 5 | 1.7% | 0.7% |
| Blank screen | 5 | 1.7% | 0.2% |
| Battery failure | 4 | 1.3% | 0.1% |
| Unit inactivated | 4 | 1.3% | 0.1% |
| Alarm, audible | 3 | 1% | 1.6% |
| Calibration error | 3 | 1% | 0% |
| Ekg/ECG analysis, failure to perform | 3 | 1% | 0.1% |
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 |
|---|---|---|
| Therapy/non-surgical treatment, aborted/stopped | 11 | 3.7% |
| Therapy/non-surgical treatment/delayed/prolonged | 9 | 3% |
| Deaththe patient died; cause not stated by this term | 6 | 2% |
| Surgical procedure, repeated | 1 | 0.3% |
| Therapy/non-surgical treatment, additional | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | System 97e | Product code DSP | All MAUDE reports |
|---|---|---|---|
| Reports | 298 | 68,628 | 26,136,888 |
| Share of that pool | — | 0.4% | 0% |
| Classified as death, per 1,000 reports | 13 | 21 | 9 |
| Classified as injury | 0% | 7.8% | 36.2% |
| Classified as malfunction | 98% | 89.8% | 62.3% |
| Filed by the manufacturer | 100% | 96.7% | 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 DSP
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Cardiosave Hybrid Type B Plug | 13,759 | 2,631 | 0.4% |
| Cs300 | 4,197 | 3 | 1.9% |
| CS300 Intra-Aortic Balloon Pump, English, 110V | 2,976 | 466 | 0.3% |
| Cardiosave Hybrid W/ E/F Plug | 1,747 | 402 | 0.3% |
| Cardiosave | 1,673 | 17 | 1.7% |
| System 97 | 1,659 | 0 | 1.7% |
| Cardiosave Hybrid Type I Plug | 1,411 | 485 | 0.1% |
| Sensation Plus 8fr 50cc Iab | 1,368 | 0 | 4.8% |
| Cardiosave Hybrid Type G Plug | 1,342 | 317 | 0.4% |
| Autocat2 Wave | 1,327 | 0 | 1.4% |
| CS300 Intra-Aortic Balloon Pump, English, 220V | 1,146 | 207 | 0.2% |
| Cs100 | 1,012 | 0 | 3.7% |
| SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet) | 985 | 491 | 1.4% |
| CS100 Intra-Aortic Balloon Pump, English, 220V | 950 | 159 | 0.4% |
| Stat Dl 9 5 Fr 40 Cc Iab | 907 | 0 | 3% |
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 System 97e reports
How many FDA reports name System 97e?
298 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 (98%) and death (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
replace (33.9%), other (for use when an appropriate device code cannot be identified) (18.1%), leak/splash (15.4%), device displays incorrect message (8.7%) and device issue (8.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that System 97e 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.