GYRUS, PK-SP GENERATOR Adverse Event — Malfunction (MDR 3003790304-2020-00002)
GYRUS, PK-SP GENERATOR Adverse Event — Malfunction (MDR 3003790304-2020-00002) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: GYRUS, PK-SP GENERATOR; Generic name: GYRUS, PK-SP GENERATOR; Manufacturer: GYRUS ACMI, INC.
| Device | GYRUS, PK-SP GENERATOR |
|---|---|
| Generic name | GYRUS, PK-SP GENERATOR |
| Manufacturer | GYRUS ACMI, INC |
| Report number | 3003790304-2020-00002 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL, USER FACI |
| Narrative | THE GENERATOR WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION A POWER TEST WAS PERFORMED AND ERROR 200 REF 92 WAS INTERMITTENTLY OBSERVED. THE ELECTRONIC ID BOARD WAS NOTED TO FREEZE DURING TESTING. IT WAS DETERMINED THAT THE MOST LIKELY CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A FAULTY PRINTED CIRCUIT BOARD. THE GENERATOR WAS REPAIRED AND RETURNED TO THE CUSTOMER. |
| Source | openFDA MAUDE (device adverse events) |
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