CARDIOSAVE HYBRID, TYPE B PLUG

Report

Report Number: 2249723-2023-01527
Event Type: Malfunction
Date Received: March 17, 2023
Date of Event: March 6, 2023
Report Date: July 10, 2025
Manufacturer: DATASCOPE CORP. - MAHWAH
Product Code: DSP
UDI-DI: 10607567108391
PMA / PMN Number: K112372
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: NURSE
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

UPDATED FIELDS: B4, G3, G6, H2, H10. CORRECTED FIELDS: H6 (INVESTIGATION CONCLUSIONS). THE FAT DEPT. RECEIVED PART NUMBER 0670-00-1182 VIDEO GEN. 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 FOUND THAT FCT FAILED WITH PROGRAM DSP ERROR. THE SUPPLIER REPLACED U53 THEN RETESTED FCT AND ICT TESTS PASSED. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED PART NUMBER 0670-00-1182 VIDEO GEN. BOARD, SERIAL NUMBER (B)(6) INTO THE CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE BOARD TO FACTORY SPECIFICATIONS PER PROCEDURE NUMBER (B)(4) REVISION E AND THE CARDIOSAVE SERVICE MANUAL PART NUMBER (B)(4) REVISION R. THE BOARD PASSED TESTING. RETAINING THE BOARD IN THE FAT PER PROCEDURE.

Additional Manufacturer Narrative · 0

A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT AND COULD NOT CONFIRM THE REPORTED ISSUE. THE FSE REPLACED VIDEO CONTROLLER KIT DUE TO CUSTOMER'S EXPLANATION AND WHAT THE FAULT LOGS INDICATED 118 & 111. THE FSE COMPLETED ALL SAFETY, FUNCTIONALITY, AND CALIBRATION CHECKS AND ALL TESTS PASSED TO FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. THE FOLLOWING INVESTIGATION WAS PERFORMED BY THE TECHNICIAN OF THE FAILURE ANALYSIS AND TESTING (FAT) WAYNE, NJ. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PARTS. 0670-00-1183, S/N, (B)(6). 0670-00-1182, S/N, (B)(6). 0012-00-1845, S/N, (B)(6). 0040-00-0456 (KIT) 0040-00-0456 (KIT) IS A KIT MADE UP OF THE FOLLOWING PARTS NUMBERS 0670-00-1183, S/N, (B)(6). 0670-00-1182, S/N, (B)(6). 0012-00-1845, S/N, (B)(6). THESE PARTS WERE RECEIVED WITH A REPORTED OF THE UNIT SCREEN WAS FROZEN AND SHUT DOWN WITH NO SYS FAILURE TONE, WITH ERROR CODES 118, 111. PERFORMED VISUAL INSPECTION OF ALL PARTS RECEIVED AND LOOKS TO BE IN A GOOD CONDITION. THIS IS A 3 PART COMPLAINT, ALL PARTS WERE TESTED TOGETHER AND THEN INDIVIDUALLY. 1-THE FOLLOWING INVESTIGATION WAS PERFORMED BY THE TECHNICIAN OF THE FAILURE ANALYSIS AND TESTING (FAT) WAYNE, NJ. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED A THE VIDEO GENERATOR BOARD WITH A REPORTED THAT THE UNIT SCREEN WAS FROZEN AND SHUT DOWN WITH NO SYS FAILURE TONE WITH ERROR CODES 118, 111, PERFORMED VISUAL INSPECTION OF THE VIDEO GENERATOR BOARD PER THE CARDIOSAVE SERVICE MANUAL AND FOUND NO VISUAL DAMAGE AND THE PART LOOKS TO BE IN GOOD CONDITION. INSTALLED THE FRONT END BOARD INTO FAILURE ANALYSIS AND TESTING IABP CARDIOSAVE TEST FIXTURE. PERFORMED AND TESTED THE VIDEO GENERATOR BOARD IN ACCORDANCE WITH PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL, IN AN ATTEMPT TO RECREATE THE REPORTED PROBLEM. THE TESTS DID TRIGGER THE REPORTED PROBLEM OF THE UNIT SCREEN FROZEN AND SHUT DOWN. THE FAILURE ANALYSIS AND TESTING DEPARTMENT WAS ABLE TO VERIFY THE FAILURE EXPERIENCED BY THE CUSTOMER. SENDING THE VIDEO GENERATOR BOARD TO THE SUPPLIER FOR FAILURE ANALYSIS AS PER PROCEDURE. THE ROOT CAUSE SELECTION FOR THIS INVESTIGATION WILL BE ¿IMPOSSIBLE TO DEFINE¿ DUE TO THE DEPARTMENT NOT HAVING THE CAPABILITIES TO INTERNALLY FURTHER TROUBLESHOOT THIS PART IN AN ATTEMPT TO DETERMINE THE ROOT CAUSE. 2-THE FOLLOWING INVESTIGATION WAS PERFORMED BY THE TECHNICIAN OF THE FAILURE ANALYSIS AND TESTING (FAT) WAYNE, NJ. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PARTS, UPPER DISPLAY MONITOR AND CABLE ASSY UPPER DISPLAY MONITOR, WITH A REPORTED OF THE UNIT SCREEN WAS FROZEN AND SHUT DOWN WITH NO SYS FAILURE TONE, WITH ERROR CODES 118, 111. INSTALLED THE PARTS INTO CARDIOSAVE TEST FIXTURE. PERFORMED AND TESTED ALL PARTS JOINTLY AND SEPARATE ACCORDANCE WITH PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL IN AN ATTEMPT TO RECREATE THE REPORTED PROBLEM. THE TESTS DID NOT TRIGGER THE REPORTED PROBLEM OF THE UNIT SCREEN WAS FROZEN AND SHUT DOWN WITH NO SYS FAILURE TONE, WITH ERROR CODES 118, 111. THE FAILURE ANALYSIS AND TESTING DEPARTMENT WAS UNABLE TO REPLICATE THE FAILURE EXPERIENCED BY THE CUSTOMER. SENDING THE UPPER DISPLAY MONITOR AND THE CABLE ASSY UPPER DISPLAY MONITOR TO THE SUPPLIER FOR FAILURE ANALYSIS AS PER PROCEDURE. THE ROOT CAUSE SELECTION FOR THIS INVESTIGATION WILL BE ¿NOT CONFIRMED' DUE TO THE FAILURE ANALYSIS AND TESTING DEPARTMENT WAS UNABLE TO REPLICATE THE FAILURE. THE FOLLOWING WAS SUBMITTED BY THE SUPERVISOR OF THE FAILURE ANALYSIS AND TESTING DEPARTMENT(FAT) WAYNE, NJ. THE SUPPLIER PERFORMED THEIR INVESTIGATION INTO THE ROOT CAUSE OF PART NUMBER. WITHIN THE SUPPLIER FAILURE ANALYSIS REPORT IT WAS DOCUMENTED THAT A VISUAL CHECK WAS PERFORMED, AND FOUND NO ABNORMALITIES. THE SUPPLIER PERFORMED A FUNCTIONAL TEST AND FOUND THE BOARD TO BE IN GOOD WORKING CONDITIONS, AND PASSED THE FUNCTIONAL TEST. THE SUPPLIER'S FAILURE ANALYSIS REPORT STATES THAT "RESULTS AT INSPECTION AND TEST IS GOOD AND NO ABNORMALITIES WAS DETECTED." AS NO EVIDENCE WAS PROVIDED OF THE ROOT CAUSE, CONSIDERING THE BOARD PASSED ALL TESTS AND THE REPORTED PROBLEM COULD NOT BE REPLICATED, THE ROOT CAUSE SELECTION OF NOT CONFIRMED WILL BE SUBMITTED INTO THE ROOT CAUSE GRID. THE FOLLOWING WAS SUBMITTED BY THE SUPERVISOR OF THE FAILURE ANALYSIS AND TESTING DEPARTMENT (FAT) WAYNE, NJ. THE SUPPLIER PERFORMED THEIR INVESTIGATION INTO THE ROOT CAUSE OF PART NUMBER. WITHIN THE SUPPLIER FAILURE ANALYSIS REPORT IT WAS DOCUMENTED THAT A VISUAL CHECK AND X-RAY INSPECTION WERE PERFORMED, AND FOUND NO DEFECTS. THE SUPPLIER PERFORMED AN ICT TEST WHICH PASSED. THE SUPPLIER PERFORMED A FUNCTIONAL TEST AND FOUND THE BOARD FAILED AT THE DSP PROGRAM STEP. THE SUPPLIER'S FAILURE ANALYSIS REPORT STATES THAT IT WAS DETERMINED THE ISSUE WAS RELATED TO COMPONENT U53 BGA, WHICH WAS REPLACED FOR VERIFICATION. UPON REPLACEMENT OF U53 THE BOARD PASSED THE FUNCTIONAL TEST. THE SUPPLIER'S FAILURE ANALYSIS STATES THE FOLLOWING: "THE CAUSE OF "UNIT SCREEN FROZE AND SHUT DOWN" IS INTERNAL DAMAGE INSIDE BGA U53 (IC MPC8270 POWER PC COMMUNICATIONS PROCE)". AS THE SUPPLIER'S FAILURE ANALYSIS STATES THAT THE CAUSE OF THE REPORTED PROBLEM WAS INTERNAL DAMAGE TO COMPONENT U53, THE ROOT CAUSE SELECTIONS OF ROOT CAUSED DETERMINED WILL BE SELECTED. ADDITIONALLY, CONSIDERING THE BOARD WAS MANUFACTURED IN SEPT, 2021 WHICH IS TWO YEARS PRIOR TO THE DATE OF THIS INVESTIGATION THE ADDITIONAL ROOT CAUSE SELECTION OF MANUFACTURING - SUPPLIER - ASSEMBLY WILL BE SELECTED.

Additional Manufacturer Narrative · 0

UPDATED FIELDS: B4, D8, G3, G6, H2, H11. CORRECTED FIELDS: D4 (UDI), H6 (INVESTIGATION CONCLUSIONS). ADDITIONAL VIDEO GEN. BOARD PART RECEIVED ON 15 MAY 2024 FOR EVALUATION. THE PROBABLE ROOT CAUSE FOR VIDEO GENERATOR BOARD IS PCBA DESIGN MARGINS ARE NOT COMPATIBLE WITH GPU IC. THIS MAY BE ASSOCIATED POWER, AND/OR PCIE BUS TIMING.

Additional Manufacturer Narrative · 0

A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.