BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFCARE

    MDR report key: 1641229 · Received March 22, 2010

    Report

    Report Number
    1313850-2010-00001
    Event Type
    Malfunction
    Date Received
    March 22, 2010
    Date of Event
    January 1, 2010
    Report Date
    February 19, 2010
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION INCLUDED: A REVIEW OF THE MATERIAL THICKNESS; MATERIAL MECHANICAL ELONGATION AND TENSILE TESTING; VISUAL OBSERVATION OF THE DEVICE MATERIAL AND WELDS; TREND REVIEW OF REPORTED FAILURES; AND IN-PROCESS TEST RESULTS FOR THE AFFECTED DEVICE LOT AS WELL AS PRODUCTION LOTS MANUFACTURED BEFORE AND AFTER THE SUBJECT DEVICE LOT. EVALUATION RESULTS: THE MATERIAL THICKNESS IS WITHIN SPECIFICATION TOLERANCES; MATERIAL ELONGATION AND TENSILE TESTING TO (B)(4) WERE WITHIN SPECIFIED ACCEPTABLE LEVELS; VISUAL OBSERVATION OF THE MATERIAL INDICATE NO IDENTIFIABLE MATERIAL IMPURITIES; NO EVIDENCE OF WELD PEELING, AS THE WELDS ARE INTACT INDICATING AN ACCEPTABLE MANUFACTURING PROCESS; WELD PENETRATION MEASUREMENTS ARE WITHIN SPECIFICATION; MATERIAL FAILURE OCCURRED ADJACENT TO THE MATERIAL BUTTON WELDS; TREND ANALYSIS INDICATES A (B)(4) FAILURE RATE 1/2008 TO PRESENT; PLANNED IN-PROCESS TESTING RESULTS WERE WITHIN ACCEPTABLE RANGES. AT THIS TIME NO CONCLUSION CAN BE DRAWN FROM THE FAILURE.

    Description of Event or Problem · 1

    A SC402 PAD USED WITH A CF300 PUMP FAILED AT THE BUTTON WELDS IN SUCH A WAY THAT IT BALLOONED UP ON ONE SIDE PUSHING THE PATIENT AGAINST THE SIDERAIL OF THE BED. PATIENT WAS UNINJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFCARE NONPOWERED FLOTATION THERAPY MATTRESS FNM GAYMAR INDUSTRIES, INC. SC402 K9 K0 13-02

    Patients

    Seq Age Sex Outcome Treatment
    1 CF300