MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-27 for CARDIOSAVE HYBRID TYPE B PLUG N/A 0998-00-0800-53 manufactured by Datascope Corp. - Mahwah.
[185542654]
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. A getinge field service engineer (fse) evaluated the iabp and replaced the parts for the unit and left additional parts for the customer for future consummation. The parts include: gasket, ecg cable, instructions for use addendum, transducer adapter cable, and the helium hi pressure regulator.
Patient Sequence No: 1, Text Type: N, H10
[185542655]
It was reported by a getinge clinical support specialist, sales. While performing a sales demonstration with a demo cardiosave intra-aorta balloon pump (iabp), the battery indicator went from 100% charged to the red exclamation symbol and zero charge within seconds. The battery was removed and it was noticed that the date on age to be 2016. In addition, it was mentioned that when the iabp was plugged in, the icon on the screen indicates a full battery. It was reported that the unit is not used on a patient and it is used for sales talk purposes only. The iabp will be returned to agility and service will follow up. There was no patient involved and no adverse event reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249723-2020-00515 |
| MDR Report Key | 9889908 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2013-03-01 |
| Date Added to Maude | 2020-03-27 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-03-27 |
| 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 | 2020-03-27 |