BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY BLUE RESUS BAG

    MDR report key: 3891548 · Received June 24, 2014

    Report

    Report Number
    2242551 -2014-00013
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    CAREFUSION/VITAL SIGNS
    Product Code
    BTM
    PMA / PMN Number
    K831885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION ANTICIPATED BUT HAS NOT YET BEGUN. UPON CAREFUSION'S INVESTIGATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: ONE SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE CAME WITH THE HOUSING APART FROM THE RESUSCITATOR BAG. NO VISIBLE DAMAGE WAS FOUND SUGGESTING ANY ASSEMBLY ERRORS. PICTURES WERE TAKEN SHOWING THE POSSIBLE POINTS FROM WHERE THE BAG CAME APART. THE SAMPLE WAS PUT BACK TOGETHER TO VERIFY THE CUSTOMER¿S COMPLAINT. A TEST CONSISTING OF PRESSING THE RESUSCITATOR MULTIPLE TIMES FROM WHERE IT SHOULD BE PRESSED AND THE BAG DID NOT FALL APART. WHEN THE BAG WAS (IMPROPERLY) PRESSED FROM THE NECK OF THE BAG (TOP OF THE HOUSING) IT DID COME APART. FAILURE COULD ONLY BE CONFIRMED WHEN BAG WAS PRESSED FROM THE NECK ON THE TOP OF THE HOUSING INSTEAD OF THE SECTION BELOW THE NECK. NO NUMBER WAS REPORTED BY THE CUSTOMER, OR IDENTIFIED DURING INITIAL SAMPLE ANALYSIS. UPON LATER REVIEW OF THE SAMPLE, A DATE CODE WAS FOUND ON THE PRODUCT, AND WAS USED TO TRACE BACK TO THE LOT NUMBER (LOT# 7922868).THE DEVICE HISTORY RECORD FOR LOT NUMBER 7922868 WAS REVIEWED, AND NO PROBLEMS WERE INDICATED THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. DURING THE MANUFACTURING PROCESS REVIEW, THERE IS NO EVIDENCE TO SUGGEST THE REPORTED ISSUE WAS THE RESULT OF ASSEMBLY ERROR. THE PROCESS IS SUFFICIENT TO DETECT THIS TYPE OF ISSUE PRIOR TO PACKAGING AND DISTRIBUTION. IT IS NOT LIKELY THAT THE MATERIAL USED IN THE MANUFACTURE AND PACKAGING OF THE PRODUCT CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE INVESTIGATION, THROUGH SAMPLE TESTING, WE WERE ABLE TO DUPLICATE THE REPORTED ISSUE ONLY BY APPLYING IMPROPER USE. THE REPORTED CONDITION WAS MOST LIKELY THE RESULT OF USER ERROR. CAREFUSION WILL CONTINUE TO MONITOR AND TREND THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATES THAT THE HEAD OF THE RESUSCITATOR FELL APART DURING A RESUSCITATION OF A PATIENT ON A VENTILATOR. COMPLAINT NO REPLACEMENT ORDER SENT, THE CUSTOMER MAY REQUEST A SINGLE REPLACEMENT(SAMPLE).  THE ACTUAL PART NUMBER IS 7900GR79. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014 FROM (B)(6): ATTACHED ARE TWO PICTURES THAT POINT OUT WHERE IT FELL APART.  TO MY KNOWLEDGE THERE WAS NO HARM TO THE PATIENT.  THEY FOUND ANOTHER RESUSCITATOR AND FINISHED WITHOUT ANY MORE ISSUES. THE RESUSCITATOR IN QUESTION WAS SENT BACK VIA UPS WITH THE REFERENCE NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368894 BABY BLUE RESUS BAG VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM CAREFUSION/VITAL SIGNS 7900GR79

    Patients

    Seq Age Sex Outcome Treatment
    1