FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 16244403
·
Received January 25, 2023
Report
- Report Number
- 2249723-2023-00477
- Event Type
- Malfunction
- Date Received
- January 25, 2023
- Date of Event
- June 3, 2021
- Report Date
- January 23, 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) REPLACED THE HOSPITAL CART (0997-00-1179). THE FSE COMPLETED A PREVENTIVE MAINTENANCE (PM) WITH CALIBRATION, FULL FUNCTIONAL AND SAFETY TESTS PER THE SERVICE MANUAL. THE SERVICE REPORT INDICATED THAT THE IABP WAS SAFE TO OPERATE. 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 INSTALLATION, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HOSPITAL CART HAD A CRACK ON THE LOWER CORNERS OF THE MAIN FRAME CHASSIS. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1203219 | 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 |