R SERIES DEFIBRILLATOR Adverse Event — Malfunction (MDR 1220908-2008-00255)
R SERIES DEFIBRILLATOR Adverse Event — Malfunction (MDR 1220908-2008-00255) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: R SERIES DEFIBRILLATOR; Generic name: R SERIES DEFIBRILLATOR; Manufacturer: ZOLL MEDICAL CORPORATION.
| Device | R SERIES DEFIBRILLATOR |
|---|---|
| Generic name | R SERIES DEFIBRILLATOR |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Report number | 1220908-2008-00255 |
| 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 UNK ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION. SUBSEQUENT BIOMED TESTING OF THE DEVICE OBSERVED A "PACER FAULT 02" MESSAGE IN THE ERROR LOG, HOWEVER THE MALFUNCTION WAS UNABLE TO BE DUPLICATED. |
| Source | openFDA MAUDE (device adverse events) |
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