POWERHEART AED Adverse Event — Malfunction (MDR 3014398-2008-00006)
POWERHEART AED Adverse Event — Malfunction (MDR 3014398-2008-00006) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: POWERHEART AED; Generic name: AUTOMATIC EXTERNAL DEFIBRILLATOR; Manufacturer: CARDIAC SCIENCE CORPORATION.
| Device | POWERHEART AED |
|---|---|
| Generic name | AUTOMATIC EXTERNAL DEFIBRILLATOR |
| Manufacturer | CARDIAC SCIENCE CORPORATION |
| Report number | 3014398-2008-00006 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-12 |
| Report source | User facility |
| Narrative | CUSTOMER REPORTED THAT THE POWERHEART AED WAS USED DURING A RESCUE ATTEMPT AND IT DID NOT FUNCTION PROPERLY. WHEN THE AED LID WAS OPENED AND PADS WERE PLACED ON THE PT, THE UNIT DID NOT ADVANCE BEYOND "PLACE ELECTRODES ON PT" PROMPT. USER REPLACED THE PADS; IT DID NOT RESOLVE THE PROBLEM. CUSTOMER USED ANOTHER 9200RD UNIT WHICH ADVANCED THRU THE PADS SEQUENCE AND DELIVERED SHOCKS UNTIL THE AMBULAN |
| Source | openFDA MAUDE (device adverse events) |
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