FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 16353325
·
Received February 10, 2023
Report
- Report Number
- 2249723-2023-01069
- Event Type
- Malfunction
- Date Received
- February 10, 2023
- Date of Event
- January 30, 2023
- Report Date
- April 26, 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, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE FSE THAT ENCOUNTERED THE ISSUE DISASSEMBLED THE CART TOP COVER AND SIDE PANEL. THE FSE REMOVED THE DAMAGED ASSEMBLY. THE FSE INSTALLED A NEW IV POLE (0436-00-0274), POLE LOCK (0105-00-0129), AND BUSHING (0358-00-0073). THE FSE PERFORMED A COMPLETE PM WITH FULL CALIBRATION, FUNCTIONAL TESTING, AND ELECTRICAL SAFETY CHECKS TO FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE.
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Description of Event or Problem · 0
N/A.
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) IV POLE NOT RELEASING FROM CART. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 43372 | 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. |