BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITALDIAGNOST SINGLE DETECTOR

    MDR report key: 4109541 · Received September 10, 2014

    Report

    Report Number
    3003768251-2014-00013
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Report Date
    August 13, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS GMBH DMC GMBH
    Product Code
    KPR
    PMA / PMN Number
    K982795
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO BOLTS ENSURE THAT THE TILT MODULE CANNOT BE LIFTED OUT OF THE ANCHORAGE. THESE TWO FIXATION SCREWS PREVENTING THE UNIT TO SLIDE OFF WERE MISSING. THE ISSUE CAN HAPPEN, IF INSTALLATION AND PREVENTIVE MAINTENANCE IS NOT EXECUTED AS INTENDED. THE CORRECT PLACEMENT OF THESE BOLTS IS CONTENT OF A WARNING LABEL IN THE INSTALLATION MANUAL AND IS SUPPOSED TO BE CHECKED DURING PREVENTIVE MAINTENANCE, THIS IS REQUIRED ONCE PER YEAR (THE FIXATION OF THE BUCKY MODULE IS A CHECKPOINT IN THE SERVICE DOCUMENTS). THIS SYSTEM WAS INSTALLED BY A DEALER, NOT BY PHILIPS SERVICE. THE CUSTOMER DID NOT SIGN A SERVICE CONTRACT WITH PHILIPS. DURING ANNUAL PREVENTIVE MAINTENANCE ANY LOOSE OR MISSING SCREW WOULD HAVE BEEN RECOGNIZED. IN THE REPORTED CASE NO ADEQUATE PREVENTIVE MAINTENANCE WAS PERFORMED. AFTER ADDING THE SCREWS BY A PHILIPS SERVICE ENGINEER, THE SYSTEM WORKED AS SPECIFIED AGAIN. PHILIPS LOCAL SERVICE ADVISED THE FIELD SERVICE ENGINEERS DEALING WITH THE DIGITAL RADIOGRAPHY INSTALLATION OF PROPER INSTALLATION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ON GOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT THAT DURING POSITIONING FOR A LATERAL CHEST EXAMINATION, THE DIGITAL DETECTOR FELL DOWN TO THE FLOOR. THE PT'S FOOT GOT SCRATCHED, NO TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559805 DIGITALDIAGNOST SINGLE DETECTOR SYSTEM, X-RAY, STATIONARY KPR PHILIPS MEDICAL SYSTEMS GMBH DMC GMBH 712020

    Patients

    Seq Age Sex Outcome Treatment
    1