BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPPORT ARM 177

    MDR report key: 4420209 · Received December 4, 2014

    Report

    Report Number
    8010042-2014-00549
    Event Type
    Malfunction
    Date Received
    December 4, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    IOY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    MORE INFO SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED WHEN INVESTIGATION IS FINISHED.

    Additional Manufacturer Narrative · 1

    OUR INVESTIGATION OF THE RETURNED SUPPORT ARM HAS BEEN COMPLETED. THE INVESTIGATION SHOWED NO INDICATIONS OF LOW FRICTION IN THE JOINTS. ACCORDING TO THE CUSTOMER, THEY HAD TIGHTENED THE SUPPORT ARM BEFORE RETURNING IT. THE SUPPORT ARM WAS STRETCHED OUT AND BENT SEVERAL TIMES WITHOUT FRICTION REDUCTION OR A SELF-LOWERING AT THE LEVEL OF THE JOINTS. THE SUPPORT ARM JOINTS WERE DIS-MOUNTED TO CHECK THE FRICTION RINGS. THE FRICTION RINGS WERE NOT WORN OUT OR DAMAGED. NO FAULT COULD BE CONFIRMED FROM INSPECTION OF THE FRICTION RINGS OR THE JOINTS THEMSELVES. ACCORDING TO THE INSTALLATION INSTRUCTIONS FOR THE SUPPORT ARM THE SUPPORT ARM JOINTS SHALL BE ADJUSTED IF NECESSARY. OUR CONCLUSION IS THERE IS NO FAULT WITH THE SUPPORT ARM, THE CAUSE FOR THE REPORTED INCIDENT WAS THAT THE SUPPORT ARM JOINTS WERE NOT TIGHTENED. (B)(4).

    Description of Event or Problem · 1

    IMP REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785342 SUPPORT ARM 177 IOY MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1