BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRACTIX 33

    MDR report key: 3338976 · Received August 22, 2013

    Report

    Report Number
    3003768251-2013-00005
    Event Type
    Malfunction
    Date Received
    August 22, 2013
    Report Date
    July 24, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS GMBH DMC
    Product Code
    MQB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP WILL SENT TO THE FDA. RESULTS - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP WILL BE SENT TO THE FDA. CONCLUSION - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP WILL SENT TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TUBE ARM OF THE MOBILE IS BALANCED BY A SPRING LOADED CHAIN. THE PIVOT OF THIS TUBE ARM AXIS IS WORN OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409068 PRACTIX 33 NONE MQB PHILIPS MEDICAL SYSTEMS GMBH DMC 70505

    Patients

    Seq Age Sex Outcome Treatment
    1