BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPPORT ARM 177

    MDR report key: 5015125 · Received August 13, 2015

    Report

    Report Number
    8010042-2015-00356
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Report Date
    July 24, 2015
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    IOY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFO REGARDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO INFORMATION RECEIVED, THE SUPPORT ARM BROKE AT THE JOINT ABOVE THE FIRST BEND. THE SUPPORT ARM IS BY DESIGN A CASTING PRODUCT. NO PARTS OR PICTURES WERE RECEIVED BACK FOR INVESTIGATION. NEITHER WAS INFORMATION OF HOW OR UNDER WHICH CIRCUMSTANCES THE SUPPORT ARM BROKE RECEIVED. PREVIOUS INVESTIGATIONS OF THE SUPPORT ARM LED TO A CHANGE OF THE MANUFACTURING PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARM. THIS CHANGE WAS IMPLEMENTED IN PRODUCTION DURING SEPTEMBER 2009. IT IS UNKNOWN IF THE REPORTED SUPPORT ARM WAS MANUFACTURED BEFORE, OR AFTER, THE IMPLEMENTATION OF THIS CHANGE. THEREFORE, THE CAUSE FOR THIS EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUPPORT ARM FOR THE VENTILATOR BROKE. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 1

    (B)(4). THIS FOLLOW-UP MEDWATCH WAS CREATED FROM A PREVIOUSLY RECEIVED INITIAL MEDWATCH WITH MANUFACTURER REPORT # : 8010042-2015-00356. THE ORIGINAL DATE OF THE INITIAL MEDWATCH REPORT WAS 07/24/2015. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533058 SUPPORT ARM 177 SUPPORT, ARM IOY MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1