AUTOCAT 2 WAVE GERMAN Adverse Event — Malfunction (MDR 1219856-2008-00046)
AUTOCAT 2 WAVE GERMAN Adverse Event — Malfunction (MDR 1219856-2008-00046) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AUTOCAT 2 WAVE GERMAN; Generic name: INTRA-AORTIC BALLOON PUMP PRODUCTS; Manufacturer: ARROW INTL., INC..
| Device | AUTOCAT 2 WAVE GERMAN |
|---|---|
| Generic name | INTRA-AORTIC BALLOON PUMP PRODUCTS |
| Manufacturer | ARROW INTL., INC. |
| Report number | 1219856-2008-00046 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-15 |
| Report source | Foreign, Health Professional |
| Narrative | IT WAS REPORTED, THAT WHILE THE PT WAS IN THE INTENSIVE CARE UNIT, THE PUMP ALARMED "MULTIPLE HELIUM LOSS ALARM." THE STAFF NOTICED A CONTINUED LOSS OF HELIUM ON THE BALLOON PRESSURE WAVE. THE INTRA-AORTIC BALLOON (IAB) WAS REMOVED AND ANOTHER IAB WAS INSERTED. THE PUMP ALARMED THE SAME "MULTIPLE HELIUM LOSS ALARM" AND AS A RESULT, THE PUMP WAS EXCHANGED OFF THE PT. A THIRD PARTY SERVICE ORGANIZAT |
| Source | openFDA MAUDE (device adverse events) |
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