X SERIES Adverse Event — Malfunction (MDR 1220908-2020-01139)
X SERIES Adverse Event — Malfunction (MDR 1220908-2020-01139) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: X SERIES; Generic name: DEFIBRILLATOR/PACEMAKER; Manufacturer: ZOLL MEDICAL CORPORATION.
| Device | X SERIES |
|---|---|
| Generic name | DEFIBRILLATOR/PACEMAKER |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Report number | 1220908-2020-01139 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Narrative | THE CUSTOMER'S REPORT WAS OBSERVED DURING REVIEW OF THE DEVICE ACTIVITY LOGS. HOWEVER, THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING BENCH HANDLING AND FULL FUNCTIONALITY STRESS TESTING WITHOUT DUPLICATING THE REPORT. THE DEFIB RECEPTACLE WAS REPLACED AS A PRECAUTION. THE DEVICE WAS RECERTIFIED. THE DEVICE AND A REPLACEMENT MULTI-FUNCTION CABLE WERE RETURNED TO THE CUSTOMER. THE MULTI-FUNCTION CABL |
| Source | openFDA MAUDE (device adverse events) |
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