BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHS INFANT HEEL WARMER

    MDR report key: 2097431 · Received May 4, 2011

    Report

    Report Number
    9710505-2011-00004
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    February 6, 2011
    Report Date
    April 15, 2011
    Manufacturer
    RAPID-AID CORP
    Product Code
    MPO
    PMA / PMN Number
    K040856
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF RETAINED SAMPLES WAS CONDUCTED. PRODUCTION DOCUMENTATION FOUND THAT FOR LOT # RA10295A 17 IN-PROCESS CHECKS DURING MANUFACTURING OF PRODUCT WAS COMPLETED WITH NO ISSUES OF UNITS LEAKING OR BURSTING DURING ACTIVATION. RETAIN SAMPLES OF THIS LOT WERE PULLED AND VISUALLY INSPECTED. NO DISCREPANCIES WERE FOUND WITH THE PRODUCT. SIX (6) UNITS WERE ACTIVATED AND TEMPERATURE TESTING COMPLETED. NO UNITS BURST UPON ACTIVATION AND TEMPERATURES WERE WITHIN SPECIFICATION OF 102 TO 105F. THE CLIENT PHS INDICATED PRODUCT HAD BURST IN THE HOSPITAL FROM THIS LOT. A REQUEST WAS PLACED FOR PHS TO FORWARD SAMPLES OF THESE BURSTING UNITS. NO SAMPLES HAVE BEEN FORWARDED FOR FURTHER INVESTIGATION. AS NONE OF THE SAMPLES HAVE BEEN RETURNED, FURTHER INVESTIGATION COULD NOT BE COMPLETED. NO ROOT CAUSE WAS ESTABLISHED. THIS IS CONSIDERED A FINAL REPORT.

    Description of Event or Problem · 1

    INFANT HEEL WARMER BURST/LEAKED DURING ACTIVATION. PROFESSIONAL HOSPITAL SUPPLY (PHS) QUALITY LEAD, (B)(6) INDICATED PRODUCT LEAKED ON INFANT WHEN USED IN A HOSPITAL. IT APPEARED THAT THE PRODUCT WAS LEAKING FROM BOTTOM CORNER OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHS INFANT HEEL WARMER MPO RAPID-AID CORP 537726 RA10295A

    Patients

    Seq Age Sex Outcome Treatment
    1