CELL SAVER ELITE, GERMAN Adverse Event — Malfunction (MDR 1219343-2020-00037)
CELL SAVER ELITE, GERMAN Adverse Event — Malfunction (MDR 1219343-2020-00037) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CELL SAVER ELITE, GERMAN; Generic name: CELL SAVER ELITE, GERMAN; Manufacturer: HAEMONETICS CORPORATION.
| Device | CELL SAVER ELITE, GERMAN |
|---|---|
| Generic name | CELL SAVER ELITE, GERMAN |
| Manufacturer | HAEMONETICS CORPORATION |
| Report number | 1219343-2020-00037 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THERE WAS NO PATIENT INVOLVED IN THE INCIDENT. A FIELD SERVICE ENGINEER WAS ON-SITE AND NOTICED THE SMELL WHEN PUT INTO SMART SUCTION FUNCTION. THE UNIT WAS RETURNED TO HAEMONETICS AND PART WILL BE REPLACED. THIS EVENT OCCURRED IN (B)(6) WITH A PRODUCT THAT IS NOT REGISTERED OR MARKETED WITHIN THE US. HOWEVER, HAEMONETICS HAS A SIMILAR DEVICE MARKETED AND CLEARED FOR USE BY THE FDA WHERE THE ALLEG |
| Source | openFDA MAUDE (device adverse events) |
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