CARDIOSAVE HYBRID W/ E/F PLUG
Report
- Report Number
- 2249723-2025-0000886
- Event Type
- Malfunction
- Date Received
- February 25, 2025
- Date of Event
- February 5, 2025
- Report Date
- February 9, 2026
- 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
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.DUE TO CHARACTERS LIMITATIONS, E1 (EVENT SITE NAME) IS (B)(6).
A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE FSE REPORTED THAT THEY REPLACED THE VOLUME DISK (D202-00-0142) AND SAFETY DISK (D202-00-0140) AS A PART OF PREVENTIVE MAINTENANCE. THE BEZEL (0380-00-0559), DISPLAY HINGE COVERS (0380-00-0561), AND SEAL (0354-00-0197-04) WERE REPLACED TO FIX THE ISSUE. DEVICE PASSED THE PERFORMANCE AND SAFETY CHECKS ACCORDING TO FACTORY SPECIFICATIONS.
IT WAS REPORTED BY THE GETINGE FIELD SERVICE ENGINEER (FSE) THAT DURING PREVENTIVE MAINTENANCE (PM) THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WHEN THE SCREEN IS TURNED ON, THE PLASTIC SCREEN RUBBING TOGETHER MAKES A LOUD NOISE AND IT IS TIME TO CHANGE THE SAFETY DISK AND TIDAL VOLUME DISK. THERE WAS NO PATIENT INVOLVED.
IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) PLASTIC AROUND THE SCREEN RUBS AND MADE NOISES. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO INJURY OR HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1036588 | 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 |