BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID INT TYPE G PLUG

    MDR report key: 11608135 · Received April 2, 2021

    Report

    Report Number
    2249723-2021-00705
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 16, 2021
    Report Date
    June 30, 2021
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108438
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G4, G7, H2, H6 (TYPE OF INVESTIGATION), H10, H11. CORRECTED FIELDS: H6 (INVESTIGATION FINDINGS). ANALYSIS OF PRODUCTION: (3331) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT/SERIAL NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE MANUFACTURING PROCESS AND THE REPORTED FAILURE. HISTORICAL DATA ANALYSIS: (4109) THE REVIEW OF THE HISTORICAL DATA INDICATES THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME LOT/SERIAL NUMBER AND REPORTED FAILURE MODE. TREND ANALYSIS: (4110/131) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD ((B)(6) 2019 THROUGH (B)(6) 2021) WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE. THE FSE FOUND ONE BATTERY FAULTY, AND NOT CHARGING. THE FSE RESOLVED THE ISSUE BY REPLACING THE BATTERY, LITHIUM ION, AND CHARGED THE BATTERY FOR A FEW HOURS. THE FSE VERIFIED THAT THE BATTERY PASSED TEST, AND THEN PERFORMED FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PATIENT TREATMENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD AN UNUSABLE BATTERY DETECTED IN BAY #1. NO PATIENT HARM, SERIOUS INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508535 CARDIOSAVE HYBRID INT TYPE G PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH N/A N/A 10607567108438

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN.