MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-07 for MONITORING SYSTEM manufactured by Vocera Communications, Inc..
[144677701]
Pts on ge monitors and alarm notifications being routed to nursing staff via vocera. In this particular instance, two pts, being cared for by the same nurse, had critical desaturations within seconds of one another. The monitoring system generated alarm notifications for both pts. The notifications for each pt were delivered to the vocera badge of the correct staff member. However, since the alarm notifications were delivered to the vocera within seconds of one another, the vocera did not enunciate the second pt's notification or require a second acknowledgement. When the primary rn acknowledged the first pt's alarm notification, the second pt's alarm notification was automatically acknowledged, thus the staff member was unaware of the notification for the second pt. Fortunately for the second pt, a staff member in passing heard the alarm in the room and responded, thus no pt harm. This event was able to be recreated by pulling two code blue buttons at the same time; the staff members only had to acknowledge notification for the first alarm, and the second alarm notification was cancelled out. Vocera has responded and has been able to validate the issue. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086453 |
| MDR Report Key | 8591239 |
| Date Received | 2019-05-07 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-04-22 |
| Date Added to Maude | 2019-05-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MONITORING SYSTEM |
| Generic Name | SYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITOR |
| Product Code | MSX |
| Date Received | 2019-05-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VOCERA COMMUNICATIONS, INC. |
| Brand Name | MONITORING SYSTEM |
| Generic Name | SYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITOR |
| Product Code | MSX |
| Date Received | 2019-05-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | VOCERA COMMUNICATIONS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-07 |