BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEL-E DONUT

    MDR report key: 2632706 · Received May 31, 2012

    Report

    Report Number
    3007056120-2012-00010
    Event Type
    Malfunction
    Date Received
    May 31, 2012
    Date of Event
    March 27, 2012
    Report Date
    May 1, 2012
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    FRP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON ALL AVAILABLE INFO, THE MFR CONCLUDES THAT THIS ISSUE MAY HAVE CAUSED OR CONTRIBUTED TO A FAILURE OF THE DEVICE TO PERFORM PART OR ALL OF ITS INTENDED FUNCTIONS, OR RESULTED IN SOME LEVEL OF CUSTOMER DISSATISFACTION WITH THE PERFORMANCE OF THE PRODUCT, BUT DOES NOT PRESENT AN INCREASED RISK TO PT SAFETY AND NO FURTHER ACTION IS APPROPRIATE.

    Description of Event or Problem · 1

    CHILDREN'S MEDICAL VENTURES (CHMW) REC'D A VOLUNTARY MEDWATCH (B)(4) ON (B)(4) 2012. THE REPORT DETAILED THAT THE HOSPITAL RETRIEVED A GEL-E DONUT FROM A CLEAN ROOM IN AN UNOPENED BAG. THE BAG WAS NOTED TO BE DAMP WHEN OPENED. A BLACK SPOT WAS REPORTEDLY ON THE BAG THAT APPEARED TO BE MOLD. A MOLD LIKE SUBSTANCE WAS ALSO REPORTED TO BE ON THE BACK SIDE OF THE LABEL. THE CUSTOMER REPORTED THAT THEY ARE RETAINING THE DONUT AND BAG, THERE IS NO ALLEGATION OF PT HARM. THE DEVICE IS A POSITIONING AID AND REPORTEDLY COULD NOT BE USED AS INTENDED. THE COMPLAINT ISSUE ALLEGED BY THE CUSTOMER WAS NOT ABLE TO BE CONFIRMED BECAUSE THE PRODUCT WAS NOT RETURNED TO THE MFR FOR EVAL. ALTHOUGH THE ALLEGED EVENT COULD NOT BE SUBSTANTIATED, NO RESULTING EFFECT ON A PT OR POTENTIAL USER HAS BEEN REPORTED. THE INSTRUCTIONS FOR USE STATE THAT BEFORE USE, REMOVE THE OUTER PLASTIC BAG AND WIPE ALL SURFACES WITH AN ANTIBACTERIAL AGENT. THE URETHANE BAG MAY FEEL MOIST WHEN REMOVED FROM THE PLASTIC BAG. DRY BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEL-E DONUT POSITIONING AID FRP PHILIPS RESPIRONICS, INC. 92025-A

    Patients

    Seq Age Sex Outcome Treatment
    1