BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUIPMENT DELIVERY SYSTEM , OSC-600

    MDR report key: 2072572 · Received April 21, 2011

    Report

    Report Number
    2031963-2011-00025
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 23, 2011
    Report Date
    March 23, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    BRY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE WAS EVALUATED ON SITE BY A FIELD SERVICE REPRESENTATIVE ON (B)(4) 2011. THE INITIAL REPORTER'S OCCUPATION WAS UNKNOWN AT THE TIME OF THIS REPORT. ADDITIONAL ATTEMPTS WILL BE MADE FOR THIS INFORMATION. EVALUATION SUMMARY: AFTER FURTHER EVALUATION ON SITE BY A FIELD SERVICE TECHNICIAN, IT WAS DETERMINED THAT A REDUCER RING LOCATED ON A TANDEM MOUNT BOOM AND SINGLE FLAT PANEL SUSPENSION FELL. THE INVESTIGATOR CONCLUDED THAT THERE WERE SEVERAL CONTRIBUTING FACTORS THAT LED TO THE COVER FALLING, ALL OF WHICH CAN BE ATTRIBUTED TO INSTALLATION ERROR. IN THIS INSTANCE, A NEW REDUCER RING WAS INSTALLED, AND RE-INSPECTION WAS COMPLETED. THE REDUCER RING IS A NON-STERILE ALUMINUM COSMETIC COVER THAT COULD POTENTIALLY BE LOCATED DIRECTLY OVER THE STERILE FIELD. HAD THE COVER FALLEN AT RANDOM DURING A CASE, THE COVER WOULD EXPOSE A NON-STERILE COMPONENT INTO THE STERILE FIELD AND THIS COULD POTENTIALLY CAUSE A SERIOUS/SEVERE HEALTH RISK. THIS SPECIFIC MALFUNCTION WAS IDENTIFIED PRIOR TO A PROCEDURE AND NO PATIENTS WERE INVOLVED AND NO ADVERSE EVENTS WERE REPORTED. THIS TYPE OF NON-CONFORMANCE WILL BE MONITORED FOR ADVERSE TRENDS. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT A METAL REDUCER RING COVER FELL FROM THE CEILING AND ALMOST IMPACTED A MEDICAL STUDENT IN THE HEAD. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND NO REPORTED ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUIPMENT DELIVERY SYSTEM , OSC-600 BRY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA