MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for CARDIOSAVE HYBRID TYPE B PLUG N/A 0998-00-0800-53 manufactured by Datascope Corp. - Mahwah.
[185778434]
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted. A getinge service territory manager (stm) was dispatched to evaluate the iabp and was able to confirm the reported issue. The stm was able to verify f7 led on executive processor board. To address the issue the stm replaced the executive board processor; however the iabp would not boot. The stm then replaced the front end board and performed all functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.
Patient Sequence No: 1, Text Type: N, H10
[185778435]
It was reported that during use on a patient the monitor of the cardiosave intra-aortic balloon pump (iabp) went blank followed by a high pitch squeal. The iabp was swapped to continue therapy. There was no harm or injury to patient and no adverse event was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249723-2020-00527 |
| MDR Report Key | 9903773 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-04-02 |
| Device Manufacturer Date | 2019-10-01 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 2020-03-31 |
| Model Number | N/A |
| Catalog Number | 0998-00-0800-53 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2020-03-31 |