FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 17953421
·
Received October 17, 2023
Report
- Report Number
- 2249723-2023-04482
- Event Type
- Malfunction
- Date Received
- October 17, 2023
- Date of Event
- October 9, 2023
- Report Date
- August 30, 2024
- Manufacturer
- DATASCOPE CORP.
- 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
UPDATED FIELD: B4, D9, G3, G6, H2, H3, H4, H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS,, COMPONENT, INVESTIGATION CONCLUSIONS),H10. THE GETINGE FIELD SERVICE ENGINEER (FSE) THAT DISCOVERED THE ISSUE DISASSEMBLED THE UNIT AND REPLACED THE BROKEN CABLE CONNECTION (0012-00-1562). THE UNIT HAS PASSED ALL TEST AND CALIBRATIONS AND IS NOW READY 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 PREVENTATIVE MAINTENANCE BY GETINGE FIELD SERVICE ENGINEER, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD A BROKEN FO CONNECTOR THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 95776 | 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 |