FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID W/ E/F PLUG
MDR report key: 16237500
·
Received January 24, 2023
Report
- Report Number
- 2249723-2023-00428
- Event Type
- Malfunction
- Date Received
- January 24, 2023
- Date of Event
- February 21, 2021
- Report Date
- January 11, 2023
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108414
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP. THE FSE VERIFIED THE BROKEN HINGE COVER AND REPLACED THE UPPER HINGE COVER (0380-00-0561) AND LABELS (0334-00-1809 AND 0334-00-1810-01), AND PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA (B)(4).
Description of Event or Problem · 0
IT WAS REPORTED BY A GETINGE FSE THAT DURING A REPAIR EVALUATION, IT WAS IDENTIFIED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD BROKEN HINGE COVER. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1403453 | CARDIOSAVE HYBRID W/ E/F PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-0800-55 | 10607567108414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | N/A. |