FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 16255256
·
Received January 27, 2023
Report
- Report Number
- 2249723-2023-00579
- Event Type
- Malfunction
- Date Received
- January 27, 2023
- Date of Event
- November 5, 2021
- Report Date
- March 6, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE GETINGE FIELD SERVICE ENGINEER (FSE) THAT ENCOUNTERED THE ISSUE REPLACED THE CONSOLE COVER (D441-00-0194), FLAT HEAD SCREW (D212-17-0604), WHEELS ASSEMBLY (D997-00-0588) AND HE TANK VALVE (D202-00-0104). THE FSE PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE.
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. 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 THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD CONSOLE COVER DAMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 412789 | 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 | NA | Unknown |