CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2025-0005343
- Event Type
- Malfunction
- Date Received
- December 28, 2025
- Date of Event
- December 5, 2025
- Report Date
- March 26, 2026
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
UPDATED FIELDS: B4, G1, G3, G6, H2, H6, H11. CORRECTED FIELDS: E1, E2, E3, H6(COMPONENT CODE).
DUE TO CHARACTERIZATION LIMIT IN E1 IS EVENT SITE NAME: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
ANOTHER CONTACT INFO: (B)(6). UPDATED FIELDS: B4,G3,G6,H2,H3,H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS),H11 A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) WAS ABLE TO CONFIRM THE FAILURE. AT FIRST THE FSE REPLACED THE FRONT END BOARD AND THE UNIT PASSED TESTS SUCCESSFULLY. HOWEVER IT WAS LATER DISCOVERED TO BE AN INTERMITTENT FAILURE AND THE FSE REPLACED THE FIBER OPTIC MODULE. CUSTOMER WILL RETAIN THE ORIGINAL FRONT END BOARD. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS AS PER MANUFACTURER'S SPECIFICATION.
N/A.
IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP(IABP) HAD A FIBER OPTIC ERROR MESSAGE ON SCREEN. NO HARM.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 398649 | 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 |