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 2020-03-30 for CARDIOSAVE HYBRID TYPE B PLUG N/A 0998-00-0800-53 manufactured by Datascope Corp. - Mahwah.
[185541244]
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. (b)(6). A getinge service territory manager (stm) was dispatched to evaluate the iabp unit. The stm confirmed blood intrusion led to the system failure. The stm replaced the patient interface module. The expired lithium ion batteries and expired 9 volt battery were replaced. The stm completed all safety, functionality and calibration checks and all tests passed to factory specifications. The iabp unit was cleared for clinical use and released to the customer.
Patient Sequence No: 1, Text Type: N, H10
[185541245]
It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a system failure. There were multiple error codes in the logs for system failures. The iabp is in the hospital biomed department. It is unknown if there was any patient harm/injury; however there was no adverse event reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249723-2020-00519 |
| MDR Report Key | 9898166 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-24 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| Model Number | N/A |
| Catalog Number | 0998-00-0800-53 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-30 |