BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONDASPACE EXTENSION ARM

    MDR report key: 2132247 · Received June 10, 2011

    Report

    Report Number
    2031963-2011-00045
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 16, 2011
    Report Date
    June 10, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    BRY
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. THE SERIAL NUMBER IS UNKNOWN SO THE DEVICE MANUFACTURE DATE IS UNKNOWN. DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. EVALUATION SUMMARY: IT WAS REPORTED THAT A 182MM REDUCING RING FROM CEILING PLATE FOR THE DUAL FLAT PANEL FELL OFF. IT WAS FURTHER STATED THAT THE RING HIT A HOSPITAL EMPLOYEE. UPON FURTHER INVESTIGATION IT WAS FOUND THAT THE RING THAT FELL WAS A BLANK REDUCER RING. STRYKER PROVIDES SEVERAL CONFIGURATIONS FOR MOUNTING THE SUSPENSIONS AND ONE OF THE CONFIGURATIONS IS A TANDEM MOUNTING PLATE WHICH ALLOWS TWO SUSPENSIONS OR A SUSPENSION AND BOOM TO BE MOUNTED RIGHT NEXT TO EACH OTHER. IN THIS OPERATING ROOM, THERE IS NOTHING MOUNTED NEXT TO THE OTHER SUSPENSION. ALTHOUGH THERE IS NO OTHER DEVICE MOUNTED NEXT TO THE SUSPENSION IN A TANDEM CONFIGURATION, A TANDEM CEILING COVER IS USED TO CONCEAL THE HOLE IN THE CEILING. THIS COVER IS OFTEN REFERRED TO AS A REDUCER RING OR IN THIS CASE, A BLANK REDUCER RING. IT APPEARS AS IF THE CAUSE OF THE REDUCER RING TO FALL WAS A SPRING ARM TENSION ISSUE CAUSING THE SPRING ARM OF THE LIGHTS WITHIN THE ROOM TO CONTINUE TO DRIFT UPWARDS AND IMPACT THE CEILING COVER. THIS LIKELY CAUSED THE CEILING COVER TO VIBRATE WHICH EVENTUALLY CAUSED THE REDUCER RING COVER TO COME LOOSE AND FALL. THE CEILING COVER BLANK REDUCER RING IS ATTACHED TO THE CEILING COVER VIA SEVERAL SMALL METAL FASTENING TABS AND PRESS FITS INTO ITS LOCATION. THE REDUCER RING IS A METAL COVER THAT ALLEGEDLY IMPACTED A NURSE WHEN IT FELL DURING A CASE. WHILE THERE WAS A REPORT OF A STAFF MEMBER BEING INJURED, IT IS UNKNOWN AT THIS TIME WHO THE STAFF MEMBER WAS OR WHETHER THIS CAUSED A SERIOUS OR SEVERE INJURY. THIS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    STRYKER REFERENCE#: (B)(4). (B)(6) UNIVERSITY: (B)(6) CALLED IN 182MM REDUCING RING FROM CEILING PLATE FOR THE DUAL FLAT PANEL FELL OFF. RING HIT HOSPITAL EMPLOYEE. ACCOUNT CLOSING ROOM UNTIL STRYKER CAN VERIFY STRUCTURE IS SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONDASPACE EXTENSION ARM BRY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK