BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 4095501 · Received September 8, 2014

    Report

    Report Number
    1518293-2014-00105
    Event Type
    Malfunction
    Date Received
    September 8, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    Manufacturer
    ;OEBE; F;ARSJEO,
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH SERVICE DISCUSSED WITH BIOMED INTERMITTENT ISSUES HE HAD. BIOMED MENTIONED THAT HE HAD REPAIRED A BAD X-RAY FOOTSWITCH AND THE FLUORO IMAGE WOULD INTERMITTENTLY FLUCTUATE UP AND DOWN. TECH SERVICE EXPLANTED THAT THIS COULD BE CAUSED BY A NUMBER OF ITEMS IN THE FLUORO CHAIN FROM THE SEDECAL TO THE TUBE AND BACK TO THE IMAGE INTENSIFIER (II). ON (B)(4), A FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND FOUND THE FLUORO IMAGE WAS GOING AND OUT OF FOCUS, THE TABLE DISPLAY WAS BLANK, AND THE TABLE MOTIONS WERE ERRATIC. FSE TROUBLESHOT THESE ISSUES AND RESOLVED THEM BY REPLACING THE 24V POWER SUPPLY TO THE TABLE. FSE CHECKED THE SYSTEM FOR PROPER OPERATION PER SERVICE CHECKLIST QSSRWI4.1 AND RETURNED THE UNIT TO THE CUSTOMER FOR SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE THAT DURING AN UNDETERMINED UROLOGY PROCEDURE, THE FLUORO FOOTSWITCH FAILED, AND NO FLUORO IMAGE COULD BE OBTAINED. PHYSICIAN COMPLETED THE PROCEDURE BY USING RAD IMAGING SHOTS. CUSTOMER WOULD NOT PROVIDE ANY FURTHER PATIENT OR PROCEDURAL INFORMATION OTHER THAN TO SAY THE PATIENT IS FINE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551107 HUT EXT DR FINAL ASSY-STANDARD IXR ;OEBE; F;ARSJEO, HUT EXT DR FINAL A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK