AED PLUS Adverse Event — Malfunction (MDR 1220908-2020-01209)
AED PLUS Adverse Event — Malfunction (MDR 1220908-2020-01209) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AED PLUS; Generic name: DEFIBRILLATOR; Manufacturer: ZOLL MEDICAL CORPORATION.
| Device | AED PLUS |
|---|---|
| Generic name | DEFIBRILLATOR |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Report number | 1220908-2020-01209 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN |
| Narrative | THE DEVICE WAS RETURNED TO ZOLL NETHERLANDS FOR EVALUATION; THE CUSTOMER'S REPORT WAS OBSERVED DURING INITIAL TESTING AND CONFIRMED IN A LOG REVIEW. HOWEVER, THE DEVICE WAS PUT THROUGH EXTENSIVE TESTING WITHOUT DUPLICATING THE REPORT. THE DEVICE WAS SCRAPPED. ANALYSIS OF REPORTS OF THIS TYPE HAS NOT IDENTIFIED AN INCREASE IN TREND. |
| Source | openFDA MAUDE (device adverse events) |
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