CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2025-0002994
- Event Type
- Malfunction
- Date Received
- July 14, 2025
- Date of Event
- June 30, 2025
- Report Date
- November 4, 2025
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UPDATED FIELDS: B4, G3, G6, H2, H3, H6 (MEDICAL DEVICE ¿ PROBLEM CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT, CHECKED THE LOGS AND REPLACED THE MOTOR CONTROL BOARD (0670-00-1159) AND DISPLAY HINGES AND UPPER HINGE COVER (0380-00-0561), (0105-00-0138-01, 0105-00-0138-02) TO FIX THE ISSUE. THE FSE COULD NOT DUPLICATE THE FAILURE FOR GAS LOSS BUT CONFIRMED THE DISPLAY ISSUE. ALL FUNCTIONAL AND SAFETY TEST PERFORMED.
DESPITE GOOD FAITH EFFORTS (GFES), NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ANY PERTINENT INFORMATION IS RECEIVED IN THE FUTURE, THE COMPLAINT WILL BE REOPENED AND UPDATED ACCORDINGLY.
IT WAS REPORTED BY THE CUSTOMER THAT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD GAS LEAK ALARM. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED THAT THE INTRA AORTIC BALLOON PUMP (IABP) HAD A GAS LEAK ALARM AND DISPLAY ISSUE WHERE THE COVER HINGES WERE TORN. THERE WAS NO PATIENT INVOLVED.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1316196 | 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 | N/A. |