MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-05-12 for ZOLL ZOLL M-SERIES NA manufactured by Zoll Medical Corp.
[16279512]
In 2005, at approx 2300 hrs, while working a cardiac arrest - v-fib-, the ems crew attached the zoll m series monitor to the pt. After the first shock -defibrillation- was delivered, the paramedic heard a loud pop. The zoll monitor would not deliver any add'l shocks after this incident. Error message 78 appeared on the screen of the monitor. The monitor itself continued to work, but the device would not deliver any add'l defibrillations.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035454 |
| MDR Report Key | 619911 |
| Date Received | 2005-05-13 |
| Date of Report | 2005-05-12 |
| Date of Event | 2005-05-01 |
| Date Added to Maude | 2005-07-11 |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOLL |
| Generic Name | MONITOR/DEFIBRILLATOR/PACER |
| Product Code | DRK |
| Date Received | 2005-05-12 |
| Model Number | ZOLL M-SERIES |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 609599 |
| Manufacturer | ZOLL MEDICAL CORP |
| Manufacturer Address | * BURLINGTON MA 018034420 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2005-05-13 |