FDA Adverse Event
Malfunction
Summary report: N
CARDIOSAVE HYBRID, TYPE B PLUG
MDR report key: 24578216
·
Received March 12, 2026
Report
- Report Number
- 2249723-2026-0001646
- Event Type
- Malfunction
- Date Received
- March 12, 2026
- Date of Event
- February 19, 2026
- Report Date
- April 8, 2026
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
AFTER FURTHER REVIEW IT WAS DETERMINED THAT THE EVENT WAS ALREADY REPORTED IN MFG REPORT NO: 2249723-2026-0001659. PLEASE REFER TO MFG REPORT NO: 2249723-2026-0001659 FOR ALL EVENT RELATED INFORMATION. PLEASE CANCEL MFG REPORT NO: 2249723-2026-0001646 IN YOUR DATABASE.
Additional Manufacturer Narrative · 0
(B)(6). 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 BY THE GETINGE FSE THAT DURING PM THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP(IABP) DEVICE HAD A MESSAGE OF UNUSABLE BATTERY DETECTED IN SLOT 2. THERE WAS VISIBLE EVIDENCE OF SALINE INTRUSION PRESENT. THERE WAS NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 638264 | 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 |