Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2015-05-04 | Z-1606-2015 | Class II | Terminated | The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the Pacer Off message and there may not be an alarm for asystole. Undetected asystole could result in irreversible changes in the patients condition and delayed or missed life sustaining patient treatmentDistribution: Worldwide Distribution - US including CO, MI, WI and Internationally to NETHERLANDS, FINLAND, and BELGIUM. | 110 (83 units US, 27 units OUS) | clearance family |
| 2014-06-13 | Z-2085-2014 | Class II | Terminated | Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur.Distribution: Worldwide Distribution: US nationwide, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIAN FEDERATION, ROMANIA, REUNION, QATAR, PORTUGAL, POLAND, PHILIPPINEs, PARAGUAY, PANAMA, NORWAY, NEW ZEALAND, NETHERLANDS, MYANMAR, MOROCCO, MEXICO, MALAYSIA, LITHUANIA, LEBANON, LATVIA, JORDAN, JAPAN, JAMAICA, ITALY, ISRAEL, IRELAND, IRAQ, INDONESIA, INDIA, ICELAND, HUNGARY, GREECE, GIBRALTAR, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, ECUADOR, DENMARK, CZECH REPUBLIC, CYPRUS, CROATIA, CHILE, BRUNEI, BERMUDA, BELGIUM, BANGLADESH, AUSTRIA, AUSTRALIA. | 41,992 (20,509 US; 21,483 OUS) | clearance family |
| 2014-02-28 | Z-1175-2014 | Class II | Terminated | GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These issues include both NIBP (Non-Invasive Blood Pressure) and Bed to Bed Issues.Distribution: Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CZECH REPUBLIC, FINLAND, FRANCE GERMANY, GREECE, ITALY, LITHUANIA, POLAND, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM. | 676 units OUS | clearance family |
Regulatory clearances
- 510(k)K131414Substantially equivalent (SESE) · 2013-08-28clearance family
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2018-07-19 | VAI | Voluntary action indicated | GE Medical Systems Information Technologies, Inc. | 5 |
| 2016-04-28 | NAI | No action indicated | GE Medical Systems Information Technologies | 0 |
| 2013-09-25 | VAI | Voluntary action indicated | GE Medical Systems Information Technologies, Inc. | 5 |
| 2013-05-14 | VAI | Voluntary action indicated | GE Medical Systems Information Technologies | 0 |
| 2012-10-09 | VAI | Voluntary action indicated | GE Medical Systems Information Technologies, Inc. | 6 |
| 2010-08-20 | NAI | No action indicated | GE Medical Systems Information Technologies, Inc. | 0 |
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