M SERIES Adverse Event — Malfunction (MDR 1220908-2008-00341)
M SERIES Adverse Event — Malfunction (MDR 1220908-2008-00341) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: M SERIES; Generic name: DEFIBRILLATOR/PACEMAKER; Manufacturer: ZOLL MEDICAL CORP.
| Device | M SERIES |
|---|---|
| Generic name | DEFIBRILLATOR/PACEMAKER |
| Manufacturer | ZOLL MEDICAL CORP |
| Report number | 1220908-2008-00341 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | User facility |
| Narrative | COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PT, THE DEVICE'S PACER OUTPUT RESETS TO ZERO. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION. |
| Source | openFDA MAUDE (device adverse events) |
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