BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH MRI COND FIBER OPTIC LARYN KIT

    MDR report key: 4658477 · Received March 27, 2015

    Report

    Report Number
    1044475-2015-00141
    Event Type
    Malfunction
    Date Received
    March 27, 2015
    Date of Event
    March 11, 2015
    Report Date
    March 11, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    OGH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT CASE SAMPLE WAS REC'D W/SOME OUTWARD DAMAGE NOTICEABLE TO THE PLASTIC CARRYING CASE. ONE OF THE LOCKING LATCHES WAS MISSING/BROKEN OFF THE CASE. UPON OPENING THE KIT IT WAS ALSO NOTED THAT ONE OF THE FOCS LIGHT PIPES HAD BEEN REMOVED FROM A BLADE AND WAS LAYING LOOSE IN THE CASE. ALSO, DURING VISUAL INSPECTION THE HANDLE DID NOT HAVE A BATTERY PACK INSTALLED, AND THERE WERE NO LOOSE BATTERY PACKS IN THE CARRYING CASE. SINCE THE LARYNGOSCOPE HANDLE DID NOT ARRIVE W/ A BATTERY PACK INSTALLED, A KNOWN GOOD KIT BATTERY PACK (NEW DESIGN) WAS INSTALLED INTO THE HANDLE. MULTIPLE FOCS BLADES FROM THE KIT WERE ATTACHED TO THE HANDLE AND ENGAGED. ALL OF THE BLADE LIGHTS WERE ENERGIZED W/NO FLICKERING, NO INTERRUPTIONS. THE COMPLAINT CANNOT BE CONFIRMED. NO CORRECTIVE/PREVENTATIVE ACTIONS ASSIGNED. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE MAC 2 BLADE IS FLICKERING AND FAILING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204797 RUSCH MRI COND FIBER OPTIC LARYN KIT LARYNGOSCOPE KIT OGH TELEFLEX MEDICAL 103301

    Patients

    Seq Age Sex Outcome Treatment
    1