BEUDAMED
    FDA Adverse Event Other Summary report: N

    LAERDAL SILICONE RESUSCITATOR

    MDR report key: 762510 · Received September 19, 2006

    Report

    Report Number
    9610483-2006-00215
    Event Type
    Other
    Date Received
    September 19, 2006
    Date of Event
    January 20, 2002
    Report Date
    January 22, 2002
    Manufacturer
    LAERDAL MEDICAL A.S.
    Product Code
    BTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAERDAL SILICONE RESUSCITATOR (LSR) INVOLVED IN THIS REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. THE USER FACILITY REPORTED HAVING MIS-ASSEMBLED THE LSR AS A RESULT OF THE MIS-PACKAGED REPLACEMENT LIP VALVES. THE AGE OF THE LSR IS UNKNOWN BUT THE LIP VALVES WERE DATED 1996. THE LSR DIRECTIONS FOR USE (DFU) LIST STEP BY STEP DIRECTIONS (WITH ILLUSTRATION) FOR REASSEMBLING THE LSR, INCLUDING THE STATEMENT "CAUTION: MAKE SURE THAT ONLY ONE LIP VALVE CAT. NO. 54 01 03 IS INSTALLED", AND DIRECTS THE READER TO TEST FUNCTIONS AS DESCRIBED ON PAGES 24-26. THESE TESTS ENSURE PROPER OPERATION OF THE RESUSCITATOR AFTER EACH DISASSEMBLY-REASSEMBLY IF PERFORMED. LAERDAL ALSO OFFERS A POSTER ILLUSTRATING ASSEMBLY OF THE LSR AND DESCRIBES FUNCTION TESTING. THE STORAGE SECTION OF THE LSR DFU STATES "LSRS AND/OR SPARE PARTS MAY BE PLACED IN LONG TERM STORAGE. THEY SHOULD BE PERIODICALLY INSPECTED AND TESTED (AT LEAST YEARLY) ACCORDING TO FUNCTION TESTING SECTION IN THIS MANUAL". LAERDAL MEDICAL AS (LMAS) RECOMMENDS THE HOSPITAL AUDIT THEIR ROUTINES FOR ASSEMBLY/DISASSEMBLY AND TESTING OF ALL PARTS INVOLVING LAERDAL SILICONE RESUSCITATORS.

    Description of Event or Problem · 1

    DURING AN INCIDENT IN A FOREIGN COUNTRY, IN 2002 INVOLVING A MALE PATIENT UNDERGOING OPEN HEART SURGERY, THIS RESUSCITATOR WAS USED FOR A MINUTE OR TWO BEFORE AN EXHALATION OBSTRUCTION OCCURRED LEADING TO A LIFE THREATENING SITUATION. IT WAS DISCOVERED THAT 2 LIP VALVES WERE INSTALLED IN THE PATIENT VALVE INSTEAD OF ONE. THE LIP VALVES WERE FROM A BUBBLE PACKAGE OF REPLACEMENT PARTS LABELED LOT 1496 (MANUFACTURED IN 1996) THAT HAD BEEN INCORRECTLY PACKED WITH 2 EACH INSTEAD OF 1 EACH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other