FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 15348642
·
Received September 2, 2022
Report
- Report Number
- 2249723-2022-02258
- Event Type
- Malfunction
- Date Received
- September 2, 2022
- Date of Event
- August 24, 2022
- Report Date
- March 11, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
Additional Manufacturer Narrative · 0
IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A ISSUE OF UNIT WAS DROPPED FELL 2 FEET AND WHEEL ASSEMBLY WAS BENT. THERE WAS NO PATIENT INVOLVEMENT. A GETINGE FIELD SERVICE ENGINEER EVALUATED THE UNIT AND CONFIRMED WHEEL AXEL TOOK DAMAGE AND NEEDED TO BE REPLACED. HE REPLACED WHEEL ASSEMBLY(D997-00-0588), VERIFIED UNIT CALIBRATED AND PASSES ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS, RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE.
Description of Event or Problem · 0
IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT FELL WHICH CAUSED THE AXEL TO BEND. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1575576 | 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 |