BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16235027 · Received January 24, 2023

    Report

    Report Number
    2249723-2023-00403
    Event Type
    Malfunction
    Date Received
    January 24, 2023
    Report Date
    March 30, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-ARTIC BALLOON PUMP (IABP) WAS PLUGGED IN AND POWERED OFF WITH CONSTANT BEEPING; MAKING A LOUD BEEPING NOISE. A GETINGE SERVICE TERRITORY MANAGER (STM) WAS DISPATCHED TO EVALUATE THE IABP AND WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. HOWEVER WHEN THE UNIT WAS BROUGHT TO THE FACILITY BIOMEDICAL ENGINEER (BIOMED) VERIFIED THE ISSUE ONLY OCCURRED WHEN THERE WAS A BATTERY INSTALLED IN BAY 2 (PLUGGED IN AND OFF), THE STM TESTED THE DAUGHTER BOARD TEST FUNCTION, IT WORKED ONE TIME AND THEN WOULD NOT ALARM, IT WAS INTERMITTENT. TO ADDRESS THE ISSUE, THE STM REPLACED THE DAUGHTER BOARD (0670-00-0860) AND THE BATTERY (0146-00-0146). THE STM COMPLETED A FULL CALIBRATION, FUNCTIONAL, AND SAFETY TEST, ALL PASSED TO FACTORY SPECIFICATIONS. THE STM KEPT THE UNIT IN BIOMED FOR THE NIGHT AND THEY REPORTED THAT IT WAS ALARMING IN THE MORNING. THE STM RETURNED ONSITE AND WAS THEN ABLE TO REPRODUCE THE REPORTED ISSUE, AND REPLACED THE POWER MANAGEMENT BOARD (0670-00-1162E) THE STM RE-VERIFIED CALIBRATION, FUNCTIONALITY AND SAFETY CHECKS, ALL TEST PASSED TO FACTORY SPECIFICATIONS. THE STM KEPT THE UNIT PLUGGED IN BIOMED AND RETURNED IN THE MORNING. THIS REPORT IS BEING SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW CONDUCTED IN CAPA (B)(4).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4,E1(SITE COUNTRY),G3,G6,H2,H10,H11; CORRECTED FIELD: H6(INVESTIGATION CONCLUSIONS).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-ARTIC BALLOON PUMP (IABP) WAS PLUGGED IN AND POWERED OFF WITH CONSTANT BEEPING; MAKING A LOUD BEEPING NOISE.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376245 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 Prefer Not To Disclose UNKNOWN.