M SERIES Adverse Event — Malfunction (MDR 1220908-2008-00276)
M SERIES Adverse Event — Malfunction (MDR 1220908-2008-00276) 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 | 1220908-2008-00276 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Health Professional, User facility |
| Narrative | COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A MALE PT, THE DEVICE ISSUED A "SHOCK ADVISED" PROMPT FOR A HEART RHYTHM THEY BELIEVE WAS NON-SHOCKABLE. 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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