FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 20676305
·
Received November 13, 2024
Report
- Report Number
- 2249723-2024-0004670
- Event Type
- Malfunction
- Date Received
- November 13, 2024
- Date of Event
- October 23, 2024
- Report Date
- November 12, 2024
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
A GETINGE FIELD SERVICE ENGINEER (FSE) CONFIRMED HOSPITAL CART DAMAGED. HINGES BROKEN ON DOPPLER STORAGE AND THE GROUND PRONG ON THE AC LINE CORD WAS MISSING. AC LINE CORD ASSEMBLY (D012-00-1688-21) AND CHASSIS STORAGE BINS (D441-00-0196) WERE REPLACED. COMPLETE PM PERFORMED WITH FULL CALIBRATION. DEVICE PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) , THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS FOUND TO BE DAMAGED. HINGES WERE BROKEN ON DOPPLER STORAGE AND THE GROUND PRONG ON THE AC LINE CORD WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2421494 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-53 | 10607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |