CARDIOSAVE HYBRID, 3.1 EDITION
Report
- Report Number
- 2249723-2025-0003982
- Event Type
- Malfunction
- Date Received
- September 24, 2025
- Date of Event
- September 3, 2025
- Report Date
- March 31, 2026
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
UPDATED FIELD : B4 , G3 , D9, G6 , H2 , H11 , H6(INVESTIGATION FINDINGS, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS,COMPONENT CODE), CORRECTED FIELD : D5 ,E2 , E3 , E4 , E1 ( INITIAL REPORTER , EVENT SITE EMAIL , EVENT SITE ADDRESS , EVENT SITE CITY ), G2. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) REPORTED THAT THE UPPER DISPLAY BOARD (D670-00-1183), LABEL, UPPER INSIDE BADGE (D334-00-1809) AND LABEL, PROD ID,CARDIOSAVE HYBRID (D334-00-1810-01)WAS DEFECTIVE AND REPLACED THE PART. AFTER THE REPAIR THE ISSUE DID NOT REOCCUR AND THE UNIT WAS RETURNED TO THE CUSTOMER. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PART P/N: 0670001183 C, S/N: (B)(6), PCBA UPPER DISPLAY, WITH A REPORTED UNIT FAILURE OF SCREEN DISPLAY ERROR DURING INSPECTION. THE FAT DEPT. CONDUCTED A VISUAL INSPECTION OF THE PART RECEIVED AND FOUND THAT THE PART IS IN GOOD CONDITION. THE FAT DEPARTMENT INSTALLED P/N: 0670001183 C, S/N: (B)(6), PCBA UPPER DISPLAY IN THE CARDIOSAVE TEST FIXTURE S/N: (B)(6) AND TESTED TO FACTORY SPECIFICATIONS PER CARDIOSAVE MANUAL NUMBER 0070-00-0639 REVISION R. THE FAILURE ANALYSIS AND TESTING DEPARTMENT PERFORMED THE FUNCTIONAL TEST FOR APPROXIMATELY ONE HOUR AND COULD NOT REPRODUCE OR VERIFY THE REPORTED SCREEN DISPLAY ERROR. RETAINING THE PCBA UPPER DISPLAY MONITOR IN THE FAT DEPARTMENT PER PROCEDURE.
DUE TO CHARACTERIZATION LIMIT E1:(B)(6).
UPDATED DATA: B4, G3, G6, H1, H2, H11, D9, H3. (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS). A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. THE (FSE) REPORTED THAT THE UPPER DISPLAY BOARD WAS DEFECTIVE AND REPLACED THE PART. AFTER THE REPAIR THE ISSUE DID NOT REOCCUR AND THE UNIT WAS RETURNED TO THE CUSTOMER.
N/A.
IT WAS REPORTED THAT IN CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP), SCREEN DISPLAY HAD AN ERROR AND APPEARED RED, THERE WAS NO PATIENT INVOLVED.
IT WAS REPORTED THAT DURING INSPECTION WORK, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A SCREEN DISPLAY ERROR. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 515376 | CARDIOSAVE HYBRID, 3.1 EDITION | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. | 0998-00-0800-65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |