M SERIES Adverse Event — Malfunction (MDR 1220908-2008-00216)
M SERIES Adverse Event — Malfunction (MDR 1220908-2008-00216) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: M SERIES; Generic name: DEFIBRILLATOR/PACEMAKER; Manufacturer: ZOLL MEDICAL CORPORATION.
| Device | M SERIES |
|---|---|
| Generic name | DEFIBRILLATOR/PACEMAKER |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Report number | 1220908-2008-00216 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-14 |
| Report source | User facility |
| Narrative | COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED "PACER FAULT 116" AND "PACER FAULT 117" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION. |
| Source | openFDA MAUDE (device adverse events) |
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