BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAERDAL SILICON RESUSCITATOR

    MDR report key: 2209289 · Received August 9, 2011

    Report

    Report Number
    9610483-2011-00003
    Event Type
    Death
    Date Received
    August 9, 2011
    Date of Event
    June 17, 2011
    Report Date
    August 9, 2011
    Manufacturer
    LAERDAL MEDICAL A.S.
    Product Code
    BTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRESSURE RELIEF VALVE (B)(4) IS NORMALLY CLOSED AND OPENS AT >35 CM H2O TO PREVENT STOMACH DISTENTION. THE PRESSURE RELIEF VALVE THREADS ON TO A PORT OF THE LSR'S PT VALVE HOUSING. LAERDAL MEDICAL (B)(4) PERSONNEL HAVE INTERVIEWED HOSP ER STAFF AND THE HOSP STAFF HAS INSPECTED THIS LSR. THE THREADS ON THE PRESSURE RELIEF VALVE (D/C 05-2005) AND LSR WERE UNDAMAGED. THE PRESSURE RELIEF VALVE WAS REASSEMBLED AND TESTED PER THE DFU WITH NO PROBLEMS FOUND. THE LSR WAS RETURNED TO SVC AT THE HOSP. THE LSR'S POST REASSEMBLY FUNCTIONAL TESTS WERE EXPLAINED TO THE DOCTOR. NO PRODUCT CORRECTIVE ACTIONS ARE RECOMMENDED.

    Description of Event or Problem · 1

    LAERDAL MEDICAL A.S. (LMAS) HAS INFORMED LAERDAL MEDICAL CORPORATION OF A PT INCIDENT FROM (B)(6) INVOLVING A PEDIATRIC LAERDAL SILICONE RESUSCITATOR (LSR). ON (B)(6), 2011, A PEDIATRIC LSR WAS USED TO VENTILATE A (B)(6) FEMALE IN A (B)(6) HOSPITAL'S EMERGENCY ROOM. THE PT HAD BEEN INTUBATED AND THE LSR USED FOR VENTILATIONS. THE PT'S VITAL SIGNS DID NOT IMPROVE AND SHE WAS RE-INTUBATED. SINCE THE SPO2 WAS LOW AND IT FELT LIKE AN AIR LEAK WAS PRESENT, THEY SWITCHED TO AN ADULT LSR AND CONTINUED VENTILATIONS. THE PT DID NOT IMPROVE AND PASSED AWAY. LATER, THE PEDIATRIC LSR'S THREADED PRESSURE RELIEF VALVE WAS FOUND LOOSE ON THE BED. THE MISSING RELIEF VALVE WAS NOT NOTICED DURING THE INCIDENT AND IN LATER INTERVIEWS, THE DOCTOR STATED THE LSR AIR LEAKAGE DID NOT AFFECT PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAERDAL SILICON RESUSCITATOR MANUAL RESUSCITATOR BTM LAERDAL MEDICAL A.S. CHILD RESC 4905

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Death