BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAERDAL DISPOSABLE PEEP VALVE ASSEMBLY

    MDR report key: 4926063 · Received July 16, 2015

    Report

    Report Number
    9610483-2015-00001
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    May 1, 2015
    Report Date
    June 18, 2015
    Manufacturer
    LAERDAL MEDICAL A/S
    Product Code
    BTM
    PMA / PMN Number
    K981415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING THIS EVENT THE USER INSPECTED THE EQUIPMENT AND FOUND THE PEEP VALVE WAS STUCK/CLOGGED WITH PATIENT SECRETIONS. THEY DISPOSED OF THIS VALVE AND IT WAS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER. THIS LSR AND PEEP VALVE HAD BEEN USED REPEATEDLY ON THIS ONE PATIENT THROUGHOUT THE WEEK. THEY DID NOT REPORT DOING ANY PRE-USE FUNCTIONAL TESTING OF THE LSR AND/OR PEEP DURING THIS WEEK. THE PEEP VALVE IS LABELED AS A SINGLE PATIENT USE PRODUCT. NO CORRECTIVE ACTION IS RECOMMENDED.

    Description of Event or Problem · 1

    LAERDAL MEDICAL (B)(4) HAS INFORMED LAERDAL MEDICAL CORPORATION (LMC) IN (B)(4) OF AN EVENT WHICH OCCURRED IN (B)(6). IN (B)(6) 2015 A MALE PATIENT WITH PNEUMONIA, WHO HAD BEEN IN THE HOSPITAL 6-7 DAYS, WAS INTUBATED AND HAD BEEN MECHANICALLY VENTILATED WHEN THEY WERE TO BE MANUALLY VENTILATED WITH A LAERDAL SILICON RESUSCITATOR (LSR) AND PEEP VALVE. THE LSR WAS USED AND THE NURSE NOTICED THE PATIENT WAS NOT EXHALING AND THEY PROMPTLY REMOVED THE LSR AND USED OTHER VENTILATION. THIS LSR W/PEEP VALVE HAD BEEN USED ON THIS PATIENT OFF AND ON FOR THE ENTIRE WEEK. THE PATIENT WAS NOT HARMED DURING THIS EVENT. THE PATIENT'S FINAL OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463590 LAERDAL DISPOSABLE PEEP VALVE ASSEMBLY PEEP VALVE BTM LAERDAL MEDICAL A/S 021214

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention