BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW-I-C20

    MDR report key: 8451207 · Received March 26, 2019

    Report

    Report Number
    8010042-2019-00202
    Event Type
    Malfunction
    Date Received
    March 26, 2019
    Date of Event
    March 17, 2019
    Report Date
    April 25, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K160665
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERON: (B)(4). THE LEAKING POWER BACKUP BATTERY HAS NOT BEEN AVAILABLE FOR INVESTIGATION. THE RECEIVED LOGS SHOW THAT ALARMS HAD BEEN GENERATED INDICATING THAT THE BATTERY WAS DUE FOR REPLACEMENT AS PER SERVICE MANUAL. THE POWER BACKUP BATTERY IS A SEALED ACID-LEAD RECHARGEABLE BATTERY. RECEIVED IMAGES CONFIRM THE LEAKAGE AT THE UPPER JOINT BUT WE ARE NOT ABLE TO DETERMINE THE TRUE CAUSE OF THE LEAKAGE.

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERON: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER'S REF #:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN REPLACING A FAILING INTERNAL POWER BACKUP BATTERY, OUR COMPANY REPRESENTATIVE NOTICED THAT THE BATTERY HAD LEAKED BATTERY ACID INTO THE BATTERY COMPARTMENT OF THE ANESTHESIA WORKSTATION. THERE WAS NO INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246233 FLOW-I-C20 GAS-MACHINE, ANESTHESIA BSZ MAQUET CRITICAL CARE AB C20

    Patients

    Seq Age Sex Outcome Treatment
    1