CARDIOSAVE HYBRID, TYPE B PLUG
Report
- Report Number
- 2249723-2023-01103
- Event Type
- Malfunction
- Date Received
- February 13, 2023
- Report Date
- August 20, 2024
- Manufacturer
- DATASCOPE CORP. - MAHWAH
- Product Code
- DSP
- UDI-DI
- 10607567108391
- PMA / PMN Number
- K112372
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- 003
Narratives
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.
THE FIELD SERVICE ENGINEER (FSE) THAT ENCOUNTERED THE ISSUE REPLACED THE POWER MANAGEMENT BOARD, BUT THE PROBLEM PERSISTED. THE FSE REPLACED THE POWER SLOT BOARD INTERFACE AND THE PROBLEM WAS RESOLVED. THE UNIT PASSED ALL CALIBRATION, FUNCTIONAL, AND SAFETY TESTS. THE IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED A POWER MANAGEMENT BOARD P/N 0670-00-1162, S/N (B)(6), WITH A REPORTED OF THE UNIT NOT CHARGING THE BATTERY IN SLOT #1. PERFORMED VISUAL INSPECTION OF THE POWER MANAGEMENT BOARD PER THE CARDIOSAVE SERVICE MANUAL AND FOUND NO VISUAL DAMAGE AND THE PART LOOKS TO BE IN GOOD CONDITION. INSTALLED THE POWER MANAGEMANT BOARD INTO FAILURE ANALYSIS AND TESTING DEPARTMENT IABP CARDIOSAVE TEST FIXTURE FOR TESTING OF THE REPORTED PROBLEM. PERFORMED AND TESTED THE POWER MANAGEMANT BOARD IN ACCORDANCE WITH PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL IN AN ATTEMPT TO RECREATE THE REPORTED PROBLEM. FOUND THAT ALL FUNCTIONS WERE NORMAL. THE TESTS DID NOT TRIGGER THE REPORTED PROBLEM OF THE UNIT NOT CHARGING THE BATTERY IN SLOT #1. THE FAILURE ANALYSIS AND TESTING DEPARTMENT WAS UNABLE TO REPLICATE THE FAILURE EXPERIENCED BY THE CUSTOMER. RETAINING THE POWER MANAGEMANT BOARD IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART NUMBER 0670-00-1162 REV. A, SERIAL NUMBER (B)(6); PART NUMBER 0997-00-1189 REV. A SERIAL NUMBER (B)(6). THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PARTS TO BE IN GOOD CONDITION. THE FAT INSTALLED PART NUMBER 0670-00-1162 IN CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. NO ISSUES WERE FOUND WHEN TESTING THIS PART. FAT COULD NOT REPLICATE THE REPORTED ISSUE. THIS REVISION IS OBSOLETE AND UNABLE TO BE TESTED BY A SUPPLIER. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE. THE FAT INSTALLED PART NUMBER 0997-00-1189 IN CARDIOSAVE TEST FIXTURE AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. UNABLE TO CHARGE THE BATTERY IN SLOT 1. FAT WAS ABLE TO REPLICATE THE REPORTED FAILURE ON THIS PART. SENDING THE BOARD TO THE SUPPLIER FOR FAILURE ANALYSIS PER PROCEDURE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0670-00-1170 POWER SLOT INTERFACE BOARD SERIAL NUMBER (B)(6) FROM THE SUPPLIER. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE SUPPLIER PERFORMED A VISUAL CHECK TO THE BOARD AND FOUND THAT CONNECTOR J2 WAS DAMAGED. PLEASE SEE ATTACHMENT FOR EVIDENCE OF DAMAGE. PROBABLE CAUSE OF THE FAILURE WAS DUE TO A DAMAGED J2 CONNECTOR. THE SUPPLIER REPLACED J2, TESTED THE BOARD. THE BOARD PASSED TESTING. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED PART NUMBER 0670-00-1170 POWER SLOT INTERFACE BOARD SERIAL NUMBER (B)(6) INTO THE CARDIOSAVE TEST FIXTURE AND TESTED THE BOARD TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. THE BOARD PASSED TESTING. RETAINING THE BOARD IN THE FAT PER PROCEDURE.
UPDATED SECTIONS: B4, G2(COMPANY REP ONLY), G3, G6, H2, H10, H11. CORRECTED SECTIONS: B5, B6, B7, D5, D10, E1(NAME & EMAIL), E2, E3, H6(HEALTH CLINICAL & IMPACT).
IT WAS REPORTED THAT DURING TROUBLESHOOTING, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS BATTERY WILL NOT CHARGE IN SLOT ONE.
N/A.
IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) BATTERY WILL NOT CHARGE IN SLOT ONE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1654807 | 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 | N/A.| UNKNOWN. |