FC 500 FLOW CYTOMETER Adverse Event — Malfunction (MDR 1061932-2020-00059)
FC 500 FLOW CYTOMETER Adverse Event — Malfunction (MDR 1061932-2020-00059) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FC 500 FLOW CYTOMETER; Generic name: COUNTER, DIFFERENTIAL CELL; Manufacturer: BECKMAN COULTER.
| Device | FC 500 FLOW CYTOMETER |
|---|---|
| Generic name | COUNTER, DIFFERENTIAL CELL |
| Manufacturer | BECKMAN COULTER |
| Report number | 1061932-2020-00059 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | FOREIGN, HEALTH PROFESSIONAL, U |
| Narrative | THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE AND CONFIRMED WHAT THE CUSTOMER REPORTED. TO RESOLVE THE ISSUE THE FSE REPLACED THE TARPON AMP BOARD. BEC IS FILING AN MDR FOR THIS EVENT BASED ON THE FDA CLASSIFICATION OF THE 08 JAN 2018 URGENT MEDICAL DEVICE RECALL AS A CLASS I RECALL ON 20 NOV 2018 (RECALL NUMBER Z-0471-2019 FOR FC 500; RECALL NUMBER Z-0472-2019 FOR EPICS XL/XLMCL). BEC INTERNAL IDE |
| Source | openFDA MAUDE (device adverse events) |
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