BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUM 300 EXAMINATION LIGHT ON MOBILE STAND

    MDR report key: 2493372 · Received March 12, 2012

    Report

    Report Number
    2031963-2012-00038
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 15, 2012
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    KZF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED PT INVOLVEMENT, THEREFORE, NO PT DATA EXISTS. THE CUSTOMER REPAIRED THE EXAMINATION LIGHT BY REPLACING THE KEEPER CLIP. THE LIGHT WAS NOT RETURNED TO THE MFR OR EVALUATED IN THE FIELD BY THE MFR. THE MANUFACTURE DATE IS UNK AS THE CUSTOMER COULD NOT LOCATE THE SERIAL NUMBER OF THE DEVICE. THERE IS NO EXP DATE FOR THIS PRODUCT. EVAL SUMMARY: THE KEEPER CLIP IS USED TO HOLD THE EXAMINATION LIGHT HEAD TO THE SPRING ARM. IF THE KEEPER CLIP IS MISSING, THERE IS POTENTIAL FOR THE LIGHT HEAD TO DISASSEMBLE FROM THE SPRING ARM. IT COULD NOT BE DETERMINED HOW THE KEEPER CLIP CAME TO BE MISSING, BUT IT IS POSSIBLE THAT THE KEEPER CLIP WAS NOT INSTALLED PROPERLY BY THE CUSTOMER. A NEW HARDWARE KIT WHICH INCLUDES THE KEEPER CLIP WAS SENT TO THE CUSTOMER. THE CUSTOMER INSTALLED THE KEEPER CLIP AND REPORTED THAT THE EXAMINATION LIGHT IS FUNCTIONING PROPERLY. THERE WAS NO PR INVOLVEMENT AND NO ADVERSE CONSEQUENCES REPORTED. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4): IT WAS REPORTED THAT THE KEEPER CLIP WAS MISSING IN THE VISUM 300 EXAMINATION LIGHT. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISUM 300 EXAMINATION LIGHT ON MOBILE STAND KZF STRYKER COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1