Devices › Monitor, physiological, patient(with arrhythmia detection or alarms)
Device brand name · Central station remote monitor
Xhibit Central Station: medical device reports filed with FDA
492 reports name it, 2023–2026. Manufacturer given most often on reports: Spacelabs Healthcare. Product code MHX.
- 492
- device reports naming the brand
- 0% of all MAUDE reports · about 144 a year
- 154
- reports, 12 months to August 2026
- 163 in the 12 months before
- 98.8%
- classified as malfunction
- 82.1% across the product code
- 0.8%
- classified as death, as reported
- 4 reports · not verified by FDA
492 medical device reports received by FDA name the brand "Xhibit Central Station" (central station remote monitor); the manufacturer given most often on reports is Spacelabs Healthcare; received from February 2023 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
154 reports arrived in the 12 months to August 2026, close to the 163 of 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 (98.8%), death (0.8%) and injury (0.4%); across all monitor, physiological, patient(with arrhythmia detection or alarms) reports (product code MHX) death is recorded in 5.9% and malfunction in 82.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are application program freezes or fails to launch (29.1%), unexpected shutdown (23%) and communication or transmission problem (19.9%). The patient problems coded most often are asystole and arrhythmia. 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 32,636 reports carrying product code MHX. 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 |
|---|---|---|---|
| Application program freezes or fails to launch | 143 | 29.1% | 1.5% |
| Unexpected shutdown | 113 | 23% | 1.4% |
| Communication or transmission problemthe device could not communicate or transmit | 98 | 19.9% | 6% |
| No display/image | 84 | 17.1% | 4.1% |
| Device alarm system | 12 | 2.4% | 8.1% |
| No audible alarm | 11 | 2.2% | 11.5% |
| Display or visual feedback problem | 9 | 1.8% | 3.2% |
| Application program problem | 6 | 1.2% | 2.7% |
| Complete loss of power | 6 | 1.2% | 0.5% |
| Unintended application program shut down | 6 | 1.2% | 1.9% |
| Intermittent communication failure | 5 | 1% | 0.5% |
| Computer software problema software problem | 2 | 0.4% | 0.8% |
| Data problem | 2 | 0.4% | 0.4% |
| Erratic or intermittent display | 1 | 0.2% | 0.9% |
| Inappropriate or unexpected reset | 1 | 0.2% | 1.1% |
| Insufficient device problem information | 1 | 0.2% | 1.3% |
| Low audible alarm | 1 | 0.2% | 0.1% |
| Overheating of device | 1 | 0.2% | 0.3% |
| Power problem | 1 | 0.2% | 1.6% |
| Reset problem | 1 | 0.2% | 0.3% |
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 |
|---|---|---|
| Asystole | 4 | 0.8% |
| Arrhythmia | 2 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Xhibit Central Station | Product code MHX | All MAUDE reports |
|---|---|---|---|
| Reports | 492 | 32,636 | 26,136,888 |
| Share of that pool | — | 1.5% | 0% |
| Classified as death, per 1,000 reports | 8 | 59 | 9 |
| Classified as injury | 0.4% | 11.2% | 36.2% |
| Classified as malfunction | 98.8% | 82.1% | 62.3% |
| Filed by the manufacturer | 100% | 93.4% | 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 MHX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Patient Information Center iX | 1,941 | 619 | 10.4% |
| uCor Heart Failure and Arrhythmia Management System | 1,877 | 762 | 0% |
| Tempus Pro | 1,850 | 108 | 0.5% |
| Cns-6201a | 1,720 | 0 | 0.8% |
| IntelliVue Multi Measurement Server X2 | 1,924 | 135 | 1.7% |
| Cns-6801a | 1,058 | 0 | 1.5% |
| Intellivue Information Center Ix | 952 | 0 | 7.5% |
| Intellivue X3 | 777 | 0 | 1.5% |
| Tempus Pro, Printer | 562 | 400 | 0% |
| Piic Ix Hardware | 538 | 0 | 4.6% |
| IntelliVue Multi-Measurement Module X3 | 478 | 401 | 1.7% |
| IntelliVue MX450 Patient Monitor | 448 | 123 | 7.6% |
| Pu-681ra | 437 | 222 | 1.4% |
| Cns-9700a | 393 | 0 | 0.3% |
| Arrhythmia Management System | 381 | 4 | 0% |
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 Xhibit Central Station reports
How many FDA reports name Xhibit Central Station?
492 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 154 in the latest 12 months.
What kinds of events are reported?
malfunction (98.8%), death (0.8%) and injury (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
application program freezes or fails to launch (29.1%), unexpected shutdown (23%), communication or transmission problem (19.9%), no display/image (17.1%) and device alarm system (2.4%). 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 Xhibit Central Station 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.