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.
[186000050]
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). The getinge field service engineer (fse) that encountered the issue suspected leaks from fill manifold and then drive manifold, so both were replaced. The fse replaced the drive manifold pressure transducer suspecting that a false reading was being sent. The fse found that the solenoid could be manually manipulated to draw vacuum and that k10 was not functioning correctly during vacuum and pressure stages. The fse replaced the solenoid control board and remedied the issue. The fse then performed and completed a preventive maintenance with all calibration, functional and safety checks to meet factory specifications. Unit passed all calibration, functional and safety test per factory specifications. The iabp was then released to the customer and cleared for clinical service.
Patient Sequence No: 1, Text Type: N, H10
[186000051]
It was reported that during a preventive maintenance (pm) performed by a getinge field service engineer, the cardiosave intra-aortic balloon pump (iabp) had an autofill with fault #37. There was no patient involvement, and no adverse event reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249723-2020-00504 |
| MDR Report Key | 9885524 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2016-03-01 |
| 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 |