FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 17225577
·
Received June 29, 2023
Report
- Report Number
- 2249723-2023-03035
- Event Type
- Malfunction
- Date Received
- June 29, 2023
- Date of Event
- June 23, 2023
- Report Date
- April 3, 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
- 003
Narratives
Additional Manufacturer Narrative · 0
IT WAS REPORTED BY GETINGE FIELD SERVICE ENGINEER(FSE) DURING PM THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAS BROKEN FIBER OPTIC CONNECTION.NO PATIENT INVOLVEMENT. SO, FSE REPLACED FIBER OPTIC CONNECTION(D012-00-1562) , PLEASE SEE ATTACHED PM - SO FOR MEASUREMENT DETAILS . UNIT PASSES ALL FUNCTIONAL AND SAFETY CHECKS AND RETURNED TO CLINICAL USE.
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
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) UNIT HAD A CRACKED FIBER OPTIC CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 264724 | 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 | N/A. |