BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDECAL

    MDR report key: 588378 · Received April 4, 2005

    Report

    Report Number
    MW1035086
    Event Type
    Malfunction
    Date Received
    April 4, 2005
    Date of Event
    March 21, 2005
    Report Date
    March 24, 2005
    Manufacturer
    *
    Product Code
    IZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    FLUORO DID NOT STOP WHEN FOOT SWITCH WAD DEPRESSED. THERAPIST HAD TO USE EMERGENCY STOP INTERLOCK TO SHUT DOWN MACHINE.

    Description of Event or Problem · 1

    1. THE EVENT DESCRIPTION STATES THE FOLLOWING: "FLUORO DID NOT STOP WHEN FOOT SWITCH WAS DEPRESSED. THERAPIST HAD TO USE EMERGENCY STOP INTERLOCK TO SHUT DOWN MACHINE." FOR THE FLUORO TO OPERATE THE OPERATOR OR THERAPIST IN THIS CASE MUST DEPRESS THE FLUORO FOOTSWITCH AS WAS INDICATED. THE FLUORO WILL STOP WHEN THE FOOTSWITCH IS RELEASED NOT DEPRESSED. FROM THIS DESCRIPTION I HAVE TO CONCLUDE THAT THE SYSTEM WAS OPERATING NORMALLY AND THERE WAS NO SYSTEM FAULT. 2. BASED ON THE REPORT INFO, THERE IS NO WAY TO CONTACT THE SITE WHERE THIS INCIDENT WAS REPORTED AND THERE IS NO PERSON TO CONTACT. THERE IS NO INFO AS TO WHERE THIS SITE IS LOCATED AND THERE IS NO PRODUCT SERIAL NUMBER TO HELP TO LOCATE THIS PRODUCT. IT IS IMPOSSIBLE TO INVESTIGATE THIS REPORT ANY FURTHER WITHOUT MORE DETAILED INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEDECAL X-RAY GENERATOR IZO * SHF-530 *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other