BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KENTRON

    MDR report key: 1917943 · Received December 3, 2010

    Report

    Report Number
    MW5018499
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    UNOMEDICAL INC; MFR IN MEXICO; DISTRIBUTED BY KENTRON HEALTH CARE INC
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PERFORMING CPR ON A PT IN A DIALYSIS FACILITY AND USING AMBU BAG FOR RESPIRATIONS. AMBU BAG FAILED TO FUNCTION PROPERLY, WAS NOT ABLE TO GIVE BREATHS. WE HAD TO LOCATE ANOTHER AMBU BAG AND IN THE INTERIM HAD TO GIVE MOUTH TO MOUTH BREATHING. PT WAS SUCCESSFULLY RESUSCITATED. AFTER THE EVENT, NOTED THAT THE VALVE INSIDE THE AMBU BAG HAD SEPARATED AWAY FROM ITS "SEATED" POSITION AND WOULD NOT ALLOW APPROPRIATE VENTILATION/NO VENTILATION. CHECKED OUR REMAINING TWO BACK UP AMBU BAGS FOR THIS PARTICULAR MANUFACTURER AND NOTED SAME PROBLEM AFTER OPENING THE BAG IN WHICH THEY WERE SHIPPED. THE AMBU BAGS COME COMPRESSED AND BENT. DATE OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: AMBU BAG FOR RESUSCITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENTRON AMBU BAG BTM UNOMEDICAL INC; MFR IN MEXICO; DISTRIBUTED BY KENTRON HEALTH CARE INC REF KENTEX #778500 07-11

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability