FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 16264346
·
Received January 30, 2023
Report
- Report Number
- 2249723-2023-00697
- Event Type
- Malfunction
- Date Received
- January 30, 2023
- Date of Event
- March 29, 2021
- Report Date
- January 11, 2023
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE GETINGE FIELD SERVICE ENGINEER (FSE) THAT ENCOUNTERED THE ISSUE REPLACED THE LEFT AND RIGHT DISPLAY HINGES (0105-00-0138-01, 0105-00-0138-02). THE FSE COMPLETED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. THE IABP IS A RENTAL UNIT, OR FIXED ASSET, AT GETINGE JAPAN AND WILL NOT BE RETURNED TO THE CUSTOMER. THE IABP UNIT WAS CLEARED FOR USE. 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 WHILE SERVICING THE UNIT, THE GETINGE FIELD SERVICE ENGINEER (FSE) FOUND THE HINGES OF THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2946 | 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 | N/A. |