CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2023-00154
- Event Type
- Malfunction
- Date Received
- January 9, 2023
- Date of Event
- December 29, 2022
- Report Date
- June 23, 2025
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H4, H6, H10. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT BUT WAS UNABLE TO DUPLICATE THE REPORTED MALFUNCTION. THE FSE OBSERVED ERROR 63 IN THE LOGS. THE FSE REPLACED THE DISPLAY MONITOR TO VIDEO GENERATOR BOARD KIT. THE FSE VERIFIED THAT THE UNIT CALIBRATED. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN: 0040-00-0456 SN: N/A (DISPLAY KIT). PN: 0670-00-1182 SN: (B)(6) (DISPLAY KIT VIDEO GEN. BOARD). PN: 0670-00-1183 SN: (B)(6) (DISPLAY KIT UPPER DISPLAY BOARD). THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF TOUCHSCREEN ISSUES. PERFORMED VISUAL INSPECTION OF ALL PARTS RECEIVED AND PARTS LOOKS TO BE IN GOOD CONDITION. INSTALLED THE KIT VIDEO GEN. BOARD AND UPPER DISPLAY BOARD INTO THE CARDIOSAVE TEST FIXTURE AND TESTED TO THE FACTORY SPECIFICATIONS AND THE CARDIOSAVE SERVICE MANUAL. THE FAILURE ANALYSIS AND TESTING DEPARTMENT COULD NOT VERIFY THE FAILURE OF TOUCHSCREEN ISSUES. DISPLAY KIT (VIDEO GEN. BOARD AND UPPER DISPLAY BOARD) PASSED TESTING. RETAINING VIDEO GEN. BOARD PN: 0670-00-1182 SN: (B)(6) IN FAT DEPT. AS PER PROCEDURE. SENDING UPPER DISPLAY BOARD PN: 0670-00-1183 SN: (B)(6) TO THE SUPPLIER AS PER PROCEDURE. THE FOLLOWING WAS INPUT BY (B)(6), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) (B)(6), NJ: (B)(6) 2024. FAT RECEIVED PN 0670-00-1182 BACK FROM THE SUPPLIER. THE SUPPLIER STATED THEY REPLACED COMPONENT U41. THEY DID NOT STATE WHAT THE ROOT CAUSE OF THE ISSUE WAS. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.
UPDATED FIELDS: H6 (HEALTH EFFECT - CLINICAL). THE FOLLOWING WAS PERFORMED BY THE MAQUET FAILURE ANALYSIS AND TESTING (FAT) DEPARTMENT: THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN: 0040-00-0456 SN: N/A (DISPLAY KIT) PN: 0670-00-1182 SN: (B)(6) (DISPLAY KIT VIDEO GEN. BOARD) PN: 0670-00-1183 SN: (B)(6) (DISPLAY KIT UPPER DISPLAY BOARD) THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF TOUCHSCREEN ISSUES. PERFORMED VISUAL INSPECTION OF ALL PARTS RECEIVED AND PARTS LOOKS TO BE IN GOOD CONDITION. INSTALLED THE KIT VIDEO GEN. BOARD AND UPPER DISPLAY BOARD INTO THE CARDIOSAVE TEST FIXTURE SN (B)(6) AND TESTED TO THE FACTORY SPECIFICATIONS PER PN 0002-07-D016 REVISION D AND THE CARDIOSAVE SERVICE MANUAL PN 0070-00-0639 REVISION Q. THE FAILURE ANALYSIS AND TESTING DEPARTMENT COULD NOT VERIFY THE FAILURE OF TOUCHSCREEN ISSUES. DISPLAY KIT (VIDEO GEN. BOARD AND UPPER DISPLAY BOARD) PASSED TESTING. RETAINING VIDEO GEN. BOARD PN: 0670-00-1182 SN: (B)(6) IN FAT DEPT. AS PER PROCEDURE 0002-07-D008 REV AL. SENDING UPPER DISPLAY BOARD PN: 0670-00-1183 SN: (B)(6) TO THE SUPPLIER AS PER PROCEDURE 0002-07-D008 REV AL. FAT RECEIVED PN 0670-00-1182 BACK FROM THE SUPPLIER. THE SUPPLIER STATED THEY REPLACED COMPONENT U41. THEY DID NOT STATE WHAT THE ROOT CAUSE OF THE ISSUE WAS. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AQ. THE FAT DEPT RECEIVED PART NUMBER: 0670-00-1183 SERIAL NUMBER: (B)(6) FROM THE SUPPLIER. THE SUPPLIER EVALUATION STATES THE FOLLOWING: 1. PERFORM INCOMING VISUAL INSPECTION RESULT: FOUND COMPONENT AT LOCATION R5 TERMINAL DAMAGED EXPOSE THE CERAMIC. REJECT UNDER IPC- A-610. THE COMPONENT IS REQUIRED TO BE REWORKED TO PROCEED WITH FCT. THE FAT DEPT WILL RETAIN THIS PART AS PER PROCEDURE 0002-07-D008.
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
UPDATED: B4, D8, D9 (RETURN TO MANUFACTURE DATE), E1 (INITIAL REPORTER AND SITE COUNTRY), E2, E3, G1, G3, G6, H2, H6 (INVESTIGATION CONCLUSIONS), H11. CORRECTED: G2, B5. THE FOLLOWING WAS PERFORMED BY THE MAQUET FAILURE ANALYSIS AND TESTING (FAT) DEPARTMENT: THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN: 0040-00-0456 SN: N/A (DISPLAY KIT) PN: 0670-00-1182 SN: (B)(6) (DISPLAY KIT VIDEO GEN. BOARD) PN: 0670-00-1183 SN: (B)(6) (DISPLAY KIT UPPER DISPLAY BOARD) THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF TOUCHSCREEN ISSUES. PERFORMED VISUAL INSPECTION OF ALL PARTS RECEIVED AND PARTS LOOKS TO BE IN GOOD CONDITION. INSTALLED THE KIT VIDEO GEN. BOARD AND UPPER DISPLAY BOARD INTO THE CARDIOSAVE TEST FIXTURE SN (B)(6) AND TESTED TO THE FACTORY SPECIFICATIONS PER PN 0002-07-D016 REVISION D AND THE CARDIOSAVE SERVICE MANUAL PN 0070-00-0639 REVISION Q. THE FAILURE ANALYSIS AND TESTING DEPARTMENT COULD NOT VERIFY THE FAILURE OF TOUCHSCREEN ISSUES. DISPLAY KIT (VIDEO GEN. BOARD AND UPPER DISPLAY BOARD) PASSED TESTING. RETAINING VIDEO GEN. BOARD PN: 0670-00-1182 SN: (B)(6) IN FAT DEPT. AS PER PROCEDURE 0002-07-D008 REV AL. SENDING UPPER DISPLAY BOARD PN: 0670-00-1183 SN: (B)(6) TO THE SUPPLIER AS PER PROCEDURE 0002-07-D008 REV AL. FAT RECEIVED PN 0670-00-1182 BACK FROM THE SUPPLIER. THE SUPPLIER STATED THEY REPLACED COMPONENT U41. THEY DID NOT STATE WHAT THE ROOT CAUSE OF THE ISSUE WAS. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AQ. THE FAT DEPT RECEIVED PART NUMBER: 0670-00-1183 SERIAL NUMBER:(B)(6) FROM THE SUPPLIER. THE SUPPLIER EVALUATION STATES THE FOLLOWING: 1. PERFORM INCOMING VISUAL INSPECTION RESULT: FOUND COMPONENT AT LOCATION R5 TERMINAL DAMAGED EXPOSE THE CERAMIC. REJECT UNDER IPC-A-610. THE COMPONENT IS REQUIRED TO BE REWORKED TO PROCEED WITH FCT. THE FAT DEPT WILL RETAIN THIS PART AS PER PROCEDURE 0002-07-D008. TOUCH SCREEN FAILURE CAN OCCUR DUE TO THE FAILURE OF U41 TOUCHSCREEN CONTROLLER ON THE VIDEO GENERATOR BOARD. THIS FAILURE IS ADDRESSED IN CAPA # 802446 WERE IDENTIFIED FOR THE REPORTED FAILURE MODE "TOUCHSCREEN MALFUNCTION" AND PRODUCT ¿CARDIOSAVE¿. THE CAPA IS CURRENTLY IN THE "IMPLEMENTING ACTIONS" STATE. A POTENTIAL ROOT CAUSE FOR THE UPPER DISPLAY BOARD IS MISHANDLING IN SHIPPING. DESIGN - DQ, NON-LABELING WAS UTILIZED FOR THE VIDEO GENERATOR BOARD. IMPOSSIBLE TO DEFINE WAS UTILIZED FOR THE UPPER DISPLAY BOARD.
UPDATED FIELDS: B4, G3, G6, H2, H11. CORRECTED FIELD: H6 (INVESTIGATION CONCLUSIONS).
N/A.
IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD TOUCHSCREEN ISSUES.
IT WAS REPORTED THAT DURING USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A TOUCHSCREEN ISSUE.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1511126 | CARDIOSAVE HYBRID, TYPE B PLUG | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL | DSP | DATASCOPE CORP. - MAHWAH | 0998-00-0800-53 | 10607567108391 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |