MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-12-24 for ZOLL X SERIES MONITOR manufactured by Zoll Medical Corporation.
[172817223]
Zoll x series, failed to charge and deliver d-fib with pt under cpr, battery showed 2+ bars. This occurred x2, after 1 successful shock during the treatment of a pt under cardiac arrest. The resuscitation crew successfully administered 1 defib, they continued care. The pt's condition indicated the need for add'l defib. They attempted to charge the unit. The unit displayed charging error or the screen and failed to charge. This was attempted x2, checking the electrodes, cables etc without resolve. The screw replaced the units battery was successfully able to deliver add'l shocks. The pt was transported to a receiving facility but the pt's outcome is unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5091883 |
| MDR Report Key | 9519678 |
| Date Received | 2019-12-24 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-12-14 |
| Date Added to Maude | 2019-12-26 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 3 |
| Brand Name | ZOLL X SERIES MONITOR |
| Generic Name | CARDIAC MONITOR (INCL. CARDIOTACHOMETER AND RATE ALARM) |
| Product Code | DRT |
| Date Received | 2019-12-24 |
| Model Number | X SERIES |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Brand Name | ZOLL X SERIES BATTERY |
| Generic Name | CARDIAC MONITOR (INCL. CARDIOTACHOMETER AND RATE ALARM) |
| Product Code | DRT |
| Date Received | 2019-12-24 |
| Model Number | X SERIES |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-12-24 |