BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM MEDICAL LIGHTS

    MDR report key: 6114183 · Received November 18, 2016

    Report

    Report Number
    3009542956-2016-00005
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    October 27, 2016
    Report Date
    November 17, 2016
    Manufacturer
    PHILIPS BURTON
    Product Code
    KZF
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THAT AIM LIGHT HEAD BECAME DETACHED. THE STOP HAD BEEN OVER-TORQUED AND SAFETY LOCKING KEY CRACKED THE COLLAR. NO INJURIES REPORTED. IT WAS FOUND THAT THERE ARE SEVEN (7) COMPLAINTS RELATED TO THE CRACKED COLLARS THAT RESULTED IN THE LIGHT HEAD DETACHED FROM THE SPRING ARM. NO INJURIES REPORTED AMONG THE SEVEN COMPLAINTS. UPON EXAMINATION, IT WAS DISCOVERED THAT THE PLASTIC COLLARS USED TO SECURE THE SPRING ARM WERE CRACKING DUE TO OVER-TORQUED DURING INSTALLATION WHICH RESULTED IN THE LIGHT HEAD TO SEPARATE FROM THE SPRING ARM. IN ORDER TO PREVENT THIS ISSUE FROM HAPPENING, PHILIPS BURTON IS REPLACING ALL PLASTIC COLLARS WITH NEW ALUMINUM COLLARS IN THE FIELD. FIELD ACTION DECISION WAS TAKEN TO PROCEED WITH THE FIELD CORRECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AIM LIGHT HEAD BECAME DETACHED. THE STOP HAD BEEN OVER-TORQUED AND SAFETY LOCKING KEY CRACKED THE COLLAR. NO INJURIES REPORTED. IT WAS FOUND THAT THERE ARE SEVEN (7) COMPLAINTS RELATED TO THE CRACKED COLLARS THAT RESULTED IN THE LIGHT HEAD DETACHED FROM THE SPRING ARM. NO INJURIES REPORTED AMONG THE SEVEN COMPLAINTS. UPON EXAMINATION, IT WAS DISCOVERED THAT THE PLASTIC COLLARS USED TO SECURE THE SPRING ARM WERE CRACKING DUE TO OVER-TORQUED DURING INSTALLATION WHICH RESULTED IN THE LIGHT HEAD TO SEPARATE FROM THE SPRING ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764962 AIM MEDICAL LIGHTS KZF PHILIPS BURTON ALEDSC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1