BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBL PACKAGE, BASIC ASSEMBLY IN CRATE

    MDR report key: 2182245 · Received July 12, 2011

    Report

    Report Number
    2031963-2011-00068
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT, THUS NO PT DATA EXISTS. THERE IS NO EXP DATE FOR THIS PRODUCT. THE OCCUPATION OF THE INITIAL REPORTER IS UNK AT THE TIME OF THIS REPORT. THE DATE OF MANUFACTURE WAS UNK AT THE TIME OF THIS REPORT. EVAL SUMMARY: IT WAS REPORTED BY A CUSTOMER THAT THE VERTIER TABLE HAS NO CONTROL FROM EITHER THE HAND CONTROL OR THE OVERRIDE PANEL. ANYTIME A COMMAND IS ISSUED, A "BEEP" IS HARD. THE SURGICAL TABLE IS USED TO SUPPORT AND POSITION A PT FOR SURGICAL PROCEDURES IN A HOSP OPERATING ROOM. IT IS BATTERY POWERED WITH AN AC CABLE FOR RECHARGE AND IS PRIMARILY OPERATED WITH A REMOTE CONTROL, AND HAS AN OVERRIDE PANEL AS A BACKUP TO THE REMOTE. THIS TABLE WAS REPORTED TO HAVE FUNCTIONALITY ISSUES WITH THE HAND CONTROL AS WELL AS THE OVERRIDE PANEL. AT THE TIME OF THIS REPORT, FULL VERIFICATION OF THE FUNCTIONALITY OF THE OVERRIDE PANEL WAS NOT ABLE TO BE OBTAINED. THE OVERRIDE PANEL IS THE SAFETY CONSOLE IN THE TABLE. IF THERE IS A MALFUNCTION AND THE HANDHELD CONTROL DOES NOT FUNCTION, THE OVERRIDE PANEL WOULD BE USED TO ARTICULATE THE TABLE AND FINISH THE SURGERY. IF A MALFUNCTION OCCURRED WITH THE OVERRIDE PANEL DURING SURGERY,THERE COULD BE A DELAY IN THE SURGERY AND THERE MAY BE A POTENTIAL FOR PT INJURY AS A CONSEQUENCE OF THIS DELAY OR MOVING THE PT TO ANOTHER TABLE. THE ROOT CAUSE IS UNK AT THE TIME OF THIS REPORT. THE CONCLUSION OF THE EVAL IS UNK AT THE TIME OF THIS REPORT. THIS TYPE OF NON-CONFORMANCE WILL BE MONITORED FOR ADVERSE TRENDS. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ASSOCIATED WITH THIS NONCONFORMANCE. THIS IS NOT A SINGLE USE DEVICE.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED BY A CUSTOMER THAT THE VERTIER TABLE HAS NO CONTROL FROM EITHER THE HAND CONTROL OR THE OVERRIDE PANEL. ANYTIME A COMMAND IS ISSUED, A "BEEP" IS HEARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TBL PACKAGE, BASIC ASSEMBLY IN CRATE FQO STRYKER COMMUNICATIONS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK