BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAERDAL SILICONE RESUSCITATOR

    MDR report key: 1044887 · Received May 8, 2008

    Report

    Report Number
    9610483-2008-00005
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Report Date
    April 7, 2008
    Manufacturer
    LAERDAL MEDICAL A/S
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESUSCITATOR RETURNED TO LAERDAL MEDICAL AS (LMAS) WAS A HYBRID DEVICE WITH PARTS FROM AT LEAST 2 MFRS. THIS INCIDENT IS BEING REPORTED AS A MDR BECAUSE SOME LAERDAL PARTS WERE USED TO MAKE THE HYBRID DEVICE ALLEGED TO HAVE BEEN INVOLVED IN THE INCIDENT. THE RETURNED DEVICE IS BEING EXAMINED AT LMAS AND NO CONCLUSION HAS YET BEEN REACHED. AN UPDATE WILL BE FILED WHEN LAERDAL'S EVAL IS CONCLUDED.

    Description of Event or Problem · 1

    LAERDAL MEDICAL CORP WAS INFORMED IN 2008 BY LAERDAL MEDICAL AS THAT A LETTER WAS RECEIVED BY A LAERDAL DISTRIBUTOR IN ISRAEL FROM A DOCTOR ALLEGING THAT A LAERDAL DEVICE WAS CONNECTED TO A PT TUBE AND THAT PRESSURE FROM "THE 'WALL OXYGEN' WENT DIRECTLY TO THE PT, PUTTING HIM IN A SERIOUS HARM OF ACUTE HYPERINFLATION, PNEUMOTHORAX AND A RISK TO HIS LIFE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAERDAL SILICONE RESUSCITATOR MANUAL RESUSCITATOR BTM LAERDAL MEDICAL A/S CHILD RESUSCITATOR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK