BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OR BOOM, MMP200, 600MM SH

    MDR report key: 1963322 · Received January 7, 2011

    Report

    Report Number
    2031963-2011-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 2010
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    BRY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MALFUNCTION WAS OBSERVED IN AN OPERATING ROOM WHICH WAS BEING UTILIZED, BUT AFTER SEVERAL ATTEMPTS, IT IS UNK IF THE INITIAL FAILURE OCCURRED DURING A PROCEDURE OR IF THERE WERE ANY DIRECT PT INVOLVEMENT. THERE IS NO EXPIRATION DATE FOR THIS PRODUCT. A REQUEST HAS BEEN MADE TO THE ACCOUNT TO RETURN THE DEVICE ASSOCIATED WITH THE MALFUNCTION. EVALUATION SUMMARY: IT WAS REPORTED TO A SALES REP THAT A FAIRFIELD MOUNT ON THE BOOM APPEARED TO BE DAMAGED AND A CO2 CANISTER WAS ZIPPED TIED ON. UPON RECEIVING THE INFO, A REPLACEMENT PART WAS SENT OUT TO THE ACCOUNT. THE INITIAL REPORTER HAS BEEN CONTACTED SEVERAL TIMES FOR MORE INFO REGARDING THE INITIAL EVENT, PT INVOLVEMENT, AND TO RETURN THE DEVICE ASSOCIATED WITH THE MALFUNCTION FOR A THOROUGH EVALUATION. DEVICE EVALUATION HAS NOT YET BEGUN AND ROOT CAUSE IS NOT YET KNOWN. POTENTIAL RISK OF THE CO2 CANISTER FALLING CANNOT BE RULED OUT. IF THE CANISTER WERE TO FALL, THERE WOULD BE THE POTENTIAL FOR SERIOUS INJURIES TO A PT OR USER. IN THIS CASE, THERE WERE NO REPORTED ADVERSE CONSEQUENCES. 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 FAIRFIELD MOUNT ON THE BOOM APPEARED TO BE DAMAGED AND A CO2 CANISTER WAS ZIPPED TIED ON. THE MALFUNCTION WAS OBSERVED IN AN OPERATING ROOM WHICH WAS BEING UTILIZED, BUT AFTER SEVERAL ATTEMPTS, IT IS UNK IF THE INITIAL FAILURE OCCURRED DURING A PROCEDURE OR IF THERE WERE ANY DIRECT PT INVOLVEMENT. THERE WERE NO REPORTED ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OR BOOM, MMP200, 600MM SH BRY STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI