BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT MANUAL PULMONARY RESUSCITATOR

    MDR report key: 1550142 · Received August 10, 2009

    Report

    Report Number
    9680866-2009-00003
    Event Type
    Malfunction
    Date Received
    August 10, 2009
    Date of Event
    June 15, 2009
    Report Date
    July 15, 2009
    Manufacturer
    UNOMEDICAL INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THE CAUSE OF DUCK BILL VALVE FAILURE (LOOSE DUCKBILL VALVE) HAS BEEN ATTRIBUTED TO AN INCORRECT ASSEMBLY BY MANUFACTURING OPERATOR AND INSUFFICIENT FIT INTERFERENCE BETWEEN RETAINER OD AND TOP HOUSING ID. HOWEVER, THE INVESTIGATION PERFORMED BY UNOMEDICAL DEMONSTRATED THAT THE MANUAL PULMONARY RESUSCITATOR WITHOUT THE VALVE AND RETAINER RING MEETS THE REQUIREMENTS FOR TIDAL VOLUME SPECIFIED IN THE ISO (B)(4) STANDARD; THEREFORE, THIS CONDITION DOES NOT COMPROMISE THE PERFORMANCE OF THE PRODUCT. CORRECTIVE ACTIONS: AS A RESULT OF PREVIOUS COMPLAINTS, THE FOLLOWING ACTIONS WERE TAKEN IN MARCH 2008: TOP HOUSING AND RETAINER RING WERE CHANGED TO EQUIVALENT COMPONENTS WHICH HAVE A BETTER RETENTION (ALMOST DOUBLE). THESE PARTS ARE MANUFACTURED ALSO BY UNOMEDICAL BY A SPECIFIC CUSTOMER AND WE HAVE NO SIMILAR COMPLAINTS FOR THESE MPR'S SINCE THEIR INTRODUCTION IN 1999. THE INSTRUCTIONS FOR USE WERE IMPROVED ADDING MORE DETAILED INFORMATION IN HOW THE PRODUCT SHOULD BE TESTED TO IDENTIFY ANY MALFUNCTION PRIOR TO USE.

    Description of Event or Problem · 1

    ON JULY 20, 2009, UNOMEDICAL INC. WAS INFORMED BY THE CUSTOMER (B)(6) ABOUT A PROBLEM WITH THE ADULT MANUAL PULMONARY RESUSCITATOR. PATIENT EXPERIENCED CARDIAC ARREST DURING HEMODIALYSIS ON (B)(6)2009. DURING RESUSCITATIVE EFFORTS, THE PRODUCT WAS BEING USED TO VENTILATE THE PATIENT, BUT THE PRODUCT FAILED. THE VALVE BETWEEN THE BODY OF THE BAG AND THE MASK CONNECTOR BECAME DISLODGED. THIS CAUSED THE OXYGEN TO BE BYPASSED OUT A SIDE VENT INSTEAD OF VENTILATING THE PATIENT. A SECOND PRODUCT WAS USED AND THAT DEVICE ALSO FAILED IN A SIMILAR FASHION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT MANUAL PULMONARY RESUSCITATOR MANUAL PULMONARY RESUSCITATOR BTM UNOMEDICAL INC. REF KENTEX #778500 07-26

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Life Threatening