CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2025-0005203
- Event Type
- Malfunction
- Date Received
- December 23, 2025
- Date of Event
- November 22, 2025
- Report Date
- March 5, 2026
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UPDATED FIELDS: B4, B5, B6, B7, B8, G3, G6, H2, H6 (TYPE OF INVESTIGATION, HEALTH EFFECT CODE).
UPDATED FIELDS - B4, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELDS - D10. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) REPORTED THAT THE DEVICE REQUIRED THE O-RING (0354-00-0175) TO BE REPLACED. THE REPLACEMENT WAS DONE AND THE DEVICE PASSED LEAK TESTS AND WAS RETURNED TO THE CUSTOMER.
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
IT WAS REPORTED THAT DURING EQUIPMENT INSPECTION CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HELIUM GAS WAS LEAK, EVEN AFTER CYLINDER WAS EXCHANGED. THERE WAS NO PATIENT INVOLVED.
N/A.
IT WAS REPORTED THAT DURING USE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HELIUM GAS WAS LEAK, EVEN AFTER CYLINDER WAS EXCHANGED. THERE WAS NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2759491 | 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 |