MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-26 for CARDIOSAVE HYBRID TYPE B PLUG N/A 0998-00-0800-53 manufactured by Datascope Corp. - Mahwah.
[186002641]
The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event. It was reported that during preventive maintenance (pm) by a getinge service territory manager (stm), the cardiosave intra-aorta balloon pump (iabp) failed the vacuum portion of drive manifold test. To resolve the issue, the stm replaced the drive manifold and the unit passed the drive manifold test without exception several times. The fse completed pm and the iabp was calibrated. The unit passed all functional and safety tests per factory specifications. The iabp was returned to customer and cleared for clinical use. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[186002642]
It was reported that during preventive maintenance (pm) by a getinge service territory manager (stm), the cardiosave intra-aorta balloon pump (iabp) failed the drive manifold test. Since the event occurred during pm, there was no patient involvement; thus no adverse event was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249723-2020-00501 |
| MDR Report Key | 9885350 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2016-07-01 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1300 MACARTHUR BLVD |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer G1 | DATASCOPE CORP. - MAHWAH |
| Manufacturer Street | 1300 MACARTHUR BLVD |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOSAVE HYBRID TYPE B PLUG |
| Generic Name | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
| Product Code | DSP |
| Date Received | 2020-03-26 |
| Model Number | N/A |
| Catalog Number | 0998-00-0800-53 |
| Lot Number | N/A |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATASCOPE CORP. - MAHWAH |
| Manufacturer Address | 1300 MACARTHUR BLVD MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |