BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 20485156 · Received October 18, 2024

    Report

    Report Number
    2249723-2024-0004291
    Event Type
    Malfunction
    Date Received
    October 18, 2024
    Date of Event
    September 27, 2024
    Report Date
    April 7, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, B5, D8, D9, G1 (CONTACT PERSON, CONTACT OFFICE - MFG SITE), G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION, COMPONENT CODES), H11. CORRECTED FIELDS - H6 (HEALTH EFFECT - CLINICAL CODE, HEALTH EFFECT - IMPACT CODE), H8. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT AND ONSITE LOOKED IN TO LOGS, NO MAJOR FAILURES OCCURRED AROUND THE REPORTED DATE ON (B)(6) 2024. A MAJOR FAILURE WAS LOGGED ON (B)(6) 2024 (ERROR 137 (APPLICATION-LEVEL FAULT FOR CODE ON THE VIDEO (HEAD) PROCESSOR)). AS A PRECAUTION THE VIDEO GENERATOR BOARD AND POWER MANAGEMENT BOARD WAS REPLACED. VERIFIED UNIT CALIBRATED AND PASSES ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS, RETURNED TO CUSTOMER. THE INVESTIGATION WAS PERFORMED TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT). THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN 0670-00-1182, PN 0670-00-1183, PN 0012-00-1845, PN 0670-00-1162. PARTS WERE RECEIVED WITH A REPORTED FAILURE OF THE UNIT SHUTTING DOWN DURING USE AND AN ERROR CODE 137 IN LOGS. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAT INSTALLED EACH PART INDIVIDUALLY AND JOINTLY IN CARDIOSAVE TEST FIXTURE AND TESTED THE PARTS TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. NO FAILURE WAS CONFIRMED ON ANY PART. RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT SHUT OFF. UNIT WAS SWAPPED WITH KNOWN GOOD PUMP TO AVOID DELAY IN PATIENT THERAPY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT SHUT OFF. UNIT WAS SWAPPED WITH KNOWN GOOD PUMP TO AVOID DELAY IN PATIENT THERAPY. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1972452 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