BEUDAMED
    FDA Adverse Event Other Summary report: N

    KENTRON - ADULT PULMONARY RESUSCITATOR

    MDR report key: 1641103 · Received October 28, 2009

    Report

    Report Number
    9680866-2009-00004
    Event Type
    Other
    Date Received
    October 28, 2009
    Date of Event
    September 14, 2009
    Report Date
    September 29, 2009
    Manufacturer
    UNOMEDICAL S.A. DE C.V.
    Product Code
    BTM
    PMA / PMN Number
    K873286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED TO THE FDA ON OCTOBER 16, 2009. PRIOR TO THE RECEIPT OF THIS MEDWATCH FORM, UNOMEDICAL, INC. INITIATED A VOLUNTARY RECALL REGARDING CERTAIN MPRS. UNOMEDICAL, INC. IS COORDINATING CLOSELY WITH FDA ON THIS RECALL. THIRTEEN (13) COMPLAINTS INVOLVING THE MPR BAG HAVE BEEN REPORTED PREVIOUSLY. (B)(4). THIS IS THE SECOND COMPLAINT OF A SIMILAR NATURE FOR THE ITEM # 778500. NO PREVIOUS COMPLAINTS FOR THE LOT# 06-24 HAVE BEEN RECEIVED. THE PRODUCTS INVOLVED IN THE PREVIOUS COMPLAINTS HAVE RELATED PRIMARILY TO PRODUCTIONS OF 2003, 2004 OR 2005 WITH FEW PRODUCTS FROM 2006 AND 2007 IDENTIFIED. ALL PRODUCTS INVOLVED IN THE PREVIOUS COMPLAINTS WERE MANUFACTURED WITH THE TOP HOUSING AND RETAINER RING MANUFACTURED IN THE MOLDING DEPARTMENT (B)(4). ACTIONS TAKEN: JUNE 2005: A TIGHTENING OF THE ALLOWED TOLERANCES AN A CHANGE IN MATERIAL OF THE RETAINER RING. NO COMPLAINTS ON PRODUCTS MANUFACTURED AFTER JUNE 2005 WERE RECEIVED AS OF 2008. ON MARCH 2008 (LOT# 08-09): TOP HOUSING AND RETAINER RING WERE CHANGED TO EQUIVALENT COMPONENTS WHICH HAVE ENHANCED RETENTION. THESE PARTS ARE MANUFACTURED ALSO BY UNOMEDICAL AND THEY ARE USED FOR THE MANUFACTURE OF MPRS FOR ANOTHER CUSTOMER. NO SIMILAR COMPLAINTS FOR THESE MPRS HAVE BEEN REPORTED SINCE THEIR INTRODUCTION IN 1999. THE INSTRUCTIONS FOR USE WERE EXPANDED TO ADD MORE DETAILED INFO ON HOW THE PRODUCT SHOULD BE TESTED TO IDENTIFY ANY MALFUNCTION PRIOR TO USE. THERE ARE NO COMPLAINTS FOR LOOSE DUCKBILL VALVES FOR PRODUCTS MANUFACTURED AFTER MARCH 2008. CONCLUSION AND RECOMMENDATIONS: EXAMINATION OF REPORT SUBMITTED BY THE CUSTOMER AS WELL AS REVIEW OF THE RETURNED MPR UNITS DEMONSTRATED THAT THE PRODUCT DID NOT PERFORM AS INTENDED. THE INVESTIGATION PERFORMED BY UNOMEDICAL CONFIRMED THAT THE DUCKBILL VALVE AND RETAINER BECAME DISLODGED AND HAD FALLEN INSIDE THE MPR BAG. EXAMINATION OF COMPLAINTS REVEALED THAT THE POTENTIAL CAUSE OF DISLODGING WAS THE NATURE OF FIT INTERFERENCE BETWEEN RETAINER RING OD AND TOP HOUSING ID. THE RETENTION BETWEEN THESE PARTS WAS ADDRESSED WITH THE CAPA IMPLEMENTED IN MARCH 2008. THE PRODUCT INVOLVED IN THE CURRENT COMPLAINT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THOSE ACTIONS. NO SIMILAR COMPLAINTS ON PRODUCTS MANUFACTURED AFTER MARCH 2008 HAVE BEEN RECEIVED. A DECISION TO TAKE REMEDIAL ACTION WAS AGREED UPON BY UNOMEDICAL AND A RECALL OF THE PRODUCT MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THE CAPA (MARCH 2008) WAS COMMUNICATED TO THE FDA AND IS PRESENTLY UNDER THEIR REVIEW.

    Description of Event or Problem · 1

    REPORTED BY THE COMPLAINANT AS FOLLOWS ON MEDWATCH (B)(4). CARDIOPULMONARY ARREST APPROXIMATELY 15 MINUTES AFTER HEMODIALYSIS INITIATED IN OUTPATIENT DIALYSIS CLINIC. CPR INITIATED BY MEDICAL STAFF. ADULT MANUAL PULMONARY RESUSCITATOR WITH ADULT MASK AND RESERVOIR BAG WITH DEFECT. FACE MASK WITH GOOD SEAL BUT AIR ESCAPED THROUGH THE SIDE VENT PORT ON PLASTIC PART OF AMBU BAG, DUE TO MISSING VALVE. ALSO NOTED TO HAVE A LOOSE OBJECT IN AMBU BAG ITSELF, POSSIBLY THE MISSING VALVE. USE OF FIRST AMBU BAG STOPPED. SECOND AND THIRD AMBU BAG WERE FOUND TO HAVE THE SAME DEFECT OF MISSING VALVE AND WERE NOTED TO HAVE LOOSE OBJECT IN BAG ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENTRON - ADULT PULMONARY RESUSCITATOR VENTILATOR, EMERG., MANUAL (RESUSCITATOR) BTM UNOMEDICAL S.A. DE C.V. 778500 06-24

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death