CS300 Adverse Event — Malfunction (MDR 2249723-2020-00678)
CS300 Adverse Event — Malfunction (MDR 2249723-2020-00678) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CS300; Generic name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL; Manufacturer: DATASCOPE CORP. - MAHWAH.
| Device | CS300 |
|---|---|
| Generic name | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
| Manufacturer | DATASCOPE CORP. - MAHWAH |
| Report number | 2249723-2020-00678 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REQUIRED TO BE REVIEWED AS PER COMPANY STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE. A GETINGE SERVICE TERRITORY MANAGER (STM) WAS DISPATCHED TO EVALUATE THE IABP UNIT. UPON ARRIVAL, THE IABP WAS IN THE BIOMED DEPARTMENT AND WAS NOT PLUGGED IN. |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →