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 UNKNOWN IAB manufactured by Datascope Corp. - Fairfield.
[185718558]
The device has not been returned to the manufacturer so we are unable to complete an evaluation. If provided we will send a supplemental report with our additional findings. Complaint record id # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185718559]
It was reported during use on a patient, the cardiosave intra-aortic balloon pump (iabp) electrocardiogram (ecg) trigger did not work, and there was no lead. The patient was later transported to university of minnesota hospital and expired on an unknown date. In addition, it has been reported that a unknown maquet 50cc balloon was used. There was no reported malfunction on the iab.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2248146-2020-00179 |
| MDR Report Key | 9903523 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-03-12 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DOROTA WOLPIUK |
| Manufacturer Street | 15 LAW DRIVE |
| Manufacturer City | FAIRFIELD NJ 07004 |
| Manufacturer Country | US |
| Manufacturer Postal | 07004 |
| Manufacturer G1 | DATASCOPE CORP. - FAIRFIELD |
| Manufacturer Street | 15 LAW DRIVE |
| Manufacturer City | FAIRFIELD NJ 07004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN IAB |
| Generic Name | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
| Product Code | DSP |
| Date Received | 2020-03-31 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATASCOPE CORP. - FAIRFIELD |
| Manufacturer Address | 15 LAW DRIVE FAIRFIELD NJ 07004 US 07004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-31 |