FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID W/ E/F PLUG
MDR report key: 21111319
·
Received January 9, 2025
Report
- Report Number
- 2249723-2025-0000139
- Event Type
- Malfunction
- Date Received
- January 9, 2025
- Date of Event
- December 21, 2024
- Report Date
- April 10, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108414
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE COMPLAINT RECORD IS DOWNGRADED (MFG REPORT NUMBER. 2249723-2025-0000139), AS THE INFORMATION PROVIDED DOES NOT MEET THE CRITERIA OF A COMPLAINT PER THE COMPLAINT HANDLING PROCEDURE.
Additional Manufacturer Narrative · 0
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. DUE TO CHARACTER LIMITATION INITIAL REPORTER FULL NAME: (B)(6).
Description of Event or Problem · 0
IT WAS REPORTED THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) NEEDED REPLACEMENT OF BATTERY AS PER SPECIFIED PERIOD.
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY GETINGE FIELD SERVICE ENGINEER (FSE) CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) BATTERY DETERIORATED. NO INJURIES OR DEATHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1417706 | CARDIOSAVE HYBRID W/ E/F PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-55 | 10607567108414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | N/A. |