FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 16268364
·
Received January 30, 2023
Report
- Report Number
- 2249723-2023-00774
- Event Type
- Malfunction
- Date Received
- January 30, 2023
- Date of Event
- May 5, 2021
- Report Date
- January 17, 2023
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE GETINGE FIELD SERVICE ENGINEER (FSE) THAT ENCOUNTERED THE ISSUE REPLACED THE TOP COMPARTMENT DOOR (0105-00-0164). THE FSE COMPLETED ALL SAFETY, FUNCTIONALITY, AND CALIBRATION CHECKS WHICH PASSED TO FACTORY SPECIFICATIONS. THE IABP UNIT WAS CLEARED FOR CLINICAL USE AND RELEASED TO THE CUSTOMER. 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 THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE) THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A BROKEN DOOR ON THE TOP COMPARTMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS IS RELATED TO (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 732649 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-0800-53 | 10607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |