MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for ZOLL X SERIES MONITOR DEFIBRILLATOR manufactured by Zoll Medical Corporation.
[185929866]
While attempting to pre-charge the zoll x series defibrillator on a cardiac arrest prior to a pulse/rhythm check, the monitor's "energy select" function would not pop up to pick a joule setting. The monitor however, did allow for multiple energy selection and charge dumps prior to this incident. The battery was double checked to be in all the way as well as matching battery life from both the battery and the monitor. The battery was in place and both battery lives matched up. The time for a pulse/rhythm check came and the pt was in v-fib, but could not received a shock due to the inability to select a joule setting. Cpr was continued and the same battery was taken out and put right back in. The monitor was turned back on and the battery still would not display a joule setting screen. At that time i swapped the battery with the spare and the monitor which worked normally after. The battery was swapped with (b)(6) on scene after the call. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093973 |
| MDR Report Key | 9902761 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-26 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| 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 DEFIBRILLATOR |
| Generic Name | AUTOMATED EXTERNAL DEFIBRILLATOR (NON-WEARABLE) |
| Product Code | MKJ |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-26 |
| Model Number | X SERIES |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-30 |