AUTOPULSE® PLATFORM RESUSCITATION Adverse Event — Malfunction (MDR 3010617000-2020-00418)
AUTOPULSE® PLATFORM RESUSCITATION Adverse Event — Malfunction (MDR 3010617000-2020-00418) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AUTOPULSE® PLATFORM RESUSCITATION; Generic name: CARDIAC CHEST COMPRESSOR; Manufacturer: ZOLL CIRCULATION.
| Device | AUTOPULSE® PLATFORM RESUSCITATION |
|---|---|
| Generic name | CARDIAC CHEST COMPRESSOR |
| Manufacturer | ZOLL CIRCULATION |
| Report number | 3010617000-2020-00418 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THE REPORTED COMPLAINT OF "AUTOPULSE PLATFORM (SN: (B)(4)) DISPLAYED FAULT CODE 16 (TIMEOUT MOVING TO TAKE-UP POSITION) ERROR MESSAGE, AND THEN, THE AUTOPULSE POWERED OFF" WAS CONFIRMED BASED ON THE ARCHIVE DATA REVIEW AND DURING FUNCTIONAL TESTING. THE ROOT CAUSE FOR THE REPORTED COMPLAINT WAS DUE TO THE CORROSION ON THE BRAKE HOUSING AREA OF THE DRIVE TRAIN MOTOR, LIKELY DUE TO HUMIDITY. AS PER |
| Source | openFDA MAUDE (device adverse events) |
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