BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE RESUSCITATOR, INFANT

    MDR report key: 1379401 · Received March 4, 2009

    Report

    Report Number
    1217052-2009-00010
    Event Type
    Malfunction
    Date Received
    March 4, 2009
    Date of Event
    February 6, 2009
    Report Date
    February 6, 2009
    Manufacturer
    GALEMED CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THIS FACILITY FOUND A MASK THAT REPORTEDLY HAD INSUFFICIENT AIR THEY AUDITED THEIR INVENTORY AND FOUND TWO MORE UNITS WITH INSUFFICIENT AIR (LOT 071204 MFG 12/2007 EXP 12/2010 AND LOT 060519 MFG 05/2006 EXP 05/2009). RESULTS EVALUATION: INVESTIGATION: THE SUPPLIER'S INVESTIGATION STATED THAT THEY VISUALLY INSPECTED THE THREE MASKS THAT WERE RETURNED. THE ONE MASK FROM LOT 070605 HAD A CRACK AND LEAK IN THE CUSHION. THE OTHER TWO MASKS, ONE FROM LOT 060519 AND ONE FROM LOT 071204, WERE ALSO INSPECTED AND FOUND TO HAVE NO LEAK BUT DID APPEAR TO BE UNDER INFLATED. ROOT CAUSE: FOR LOT 070605 THE EVENT WAS LIKELY DUE TO WEIGHT BEING ADDED TO TOP OF CARTON DURING TRANSPORTATION OR STORAGE. FOR THE OTHER TWO LOTS THE LIKELY CAUSE ATTRIBUTED TO MASKS WERE STORED IN HIGH TEMPERATURE ENVIRONMENT AND THEY WERE PRESSED BY THE OTHER PRODUCT TO CAUSE MASK CUSHION TO BE UNDER INFLATED. GALEMED CHECKED THEIR STOCK AND HISTORY FOR THIS LOT AND NO SIMILAR REPORTS HAVE BEEN RECEIVED. THEY HAD PREVIOUSLY SET UP A HAND IMPRESSING CHECK FOR THE HARD SHELL AT THEIR INJECTION PROCESS TO MAKE SURE THAT THE HARD SHELL IS RESISTING ENOUGH BY HAND PRESSING AFTER INJECTION. THIS LOT WAS MANUFACTURED BEFORE THE HAND PRESSING CHECK WAS IMPLEMENTED. THIS REPORT HAS BEEN LOGGED FOR TRENDING.

    Description of Event or Problem · 1

    USER REPORTED HAVING ONE EVENT WHERE THE MASK WAS UNDERINFLATED. FOUND PRIOR TO USE. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1ST RESPONSE RESUSCITATOR, INFANT 73 BTM - RESUSCITATOR, PULMONARY, MANUALLY-OPERATED, SINGLE-USE BTM GALEMED CORPORATION 070605

    Patients

    Seq Age Sex Outcome Treatment
    1