SENSATION 7FR. 40CC Adverse Event — Malfunction (MDR 2248146-2020-00243)
SENSATION 7FR. 40CC Adverse Event — Malfunction (MDR 2248146-2020-00243) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SENSATION 7FR. 40CC; Generic name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL; Manufacturer: DATASCOPE CORP. - FAIRFIELD.
| Device | SENSATION 7FR. 40CC |
|---|---|
| Generic name | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
| Manufacturer | DATASCOPE CORP. - FAIRFIELD |
| Report number | 2248146-2020-00243 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. INTERNAL CAPA # 232743 IS IN PROCESS TO DETERMINE ACTIONS THAT CAN BE TAKEN TO HELP PREVENT RECURRENCE OF THIS EVENT. COMPLAINT # (B)(4). |
| Source | openFDA MAUDE (device adverse events) |
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