CARDIOSAVE HYBRID, TYPE G PLUG
Report
- Report Number
- 2249723-2025-0004800
- Event Type
- Malfunction
- Date Received
- November 23, 2025
- Date of Event
- November 3, 2025
- Report Date
- December 28, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108438
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UPDATED FIELDS- B4, D9, D10, E1 (INITIAL REPORTER, EVENT SITE EMAIL), G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND FOUND THAT THE UNIT SCREEN HAVING INTERMITTENT PROBLEMS. CHECKED THE LOGS AND NOTHING CAN BE FOUND. THE SCREEN WAS REPLACED PREVIOUSLY, BUT ISSUE CAME BACK. THE FSE EXTRACTED THE LOGS AND ESCALATED THE ISSUE TO THE FACTORY. AS PER THE QUOTATION PROVIDED TO CUSTOMER, THE EXEC PROCESSOR (0670-00-0770) AND BACKPLANE PCBA (0670-00-1163) WERE REPLACED, AND THE UNIT WAS PLACED UNDER MONITORING. AFTER A FEW DAYS, THE USER CONFIRMED THAT THE UNIT IS OK.
IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT HAD SCRREN WAS BEEN FUZZY. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A FAULTY SCREEN. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2361639 | CARDIOSAVE HYBRID, TYPE G PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-52 | 10607567108438 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |