BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 20084659 · Received August 28, 2024

    Report

    Report Number
    2249723-2024-03506
    Event Type
    Malfunction
    Date Received
    August 28, 2024
    Date of Event
    August 7, 2024
    Report Date
    December 19, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND WAS ABLE TO DUPLICATE THE REPORTED ISSUE AND VERIFIED THE FAILURE IN THE LOGS. WHEN MOVING THE FIBEROPTIC CONNECTOR SLIGHTLY THE OUTPUT WOULD CUT-OUT. THE FSE REPLACED THE FIBEROPTIC SENSOR EXTENSION ASSEMBLY (0202-00-0140 )AND FUNCTIONAL TESTED MULTIPLE TIMES WITHOUT ANY FURTHER FAILURES OR ISSUES. RELEASED TO CUSTOMER AND CLEARED FOR USE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0012-00-1562 FIBER OPTIC EXTENSION SERIAL NUMBER (B)(6) RAM WITH A REPORTED UNIT FAILURE OF FIBER OPTIC SENSOR FAILURE. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED PART NUMBER 0012-00-1562 FIBER OPTIC EXTENSION SERIAL NUMBER (B)(6) RAM INTO THE CARDIOSAVE TEST FIXTURE AND TESTED THE FIBER OPTIC EXTENSION TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. THE FAT DEPT. TESTED THE FIBER OPTIC EXTENSION IN DIAGNOSTICS IN THE FIBER OPTIC TEST, AND AFTER MULTIPLE TIMES OF PERFORMING THE FIBER OPTIC TEST AND MOVING THE FIBER OPTIC EXTENSION AROUND, THE FAT DEPT. COULD NOT REPLICATE THE FAILURE OF FIBER OPTIC SENSOR FAILURE. THE FIBER OPTIC EXTENSION PASSED TESTING. RETAINING THE FIBER OPTIC EXTENSION IN THE FAT DEPT. PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) FIBEROPTIC SENSOR FAILURE. THERE WAS NO HARM REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480109 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 N/A.| UNKNOWN.