CARDIOSAVE HYBRID INT TYPE B PLUG Adverse Event — Malfunction (MDR 2249723-2020-00682)
CARDIOSAVE HYBRID INT TYPE B PLUG Adverse Event — Malfunction (MDR 2249723-2020-00682) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CARDIOSAVE HYBRID INT TYPE B PLUG; Generic name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL; Manufacturer: DATASCOPE CORP. - MAHWAH.
| Device | CARDIOSAVE HYBRID INT TYPE B PLUG |
|---|---|
| Generic name | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
| Manufacturer | DATASCOPE CORP. - MAHWAH |
| Report number | 2249723-2020-00682 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP AND WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. HOWEVER THE FSE FOUND FAULT# 77 RECORDED IN IABP'S FAULT LOGS. THE FSE REPLACED THE SCROLL COMPRESSOR TO ADDRESS THE FAULT# 77. ALL FUNCTIONAL AND SAFETY TESTS WERE PASSED TO MEET FACTORY SPECIFICATIONS. THE IABP HAS NOT BEEN CLEARED FOR CLINICAL USE; RUNNING TEST IS BEING PERFORMED. A SUPPLEM |
| Source | openFDA MAUDE (device adverse events) |
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