BEUDAMED
    FDA Adverse Event Other Summary report: N

    LAERDAL SILICONE RESUSCITATOR

    MDR report key: 762567 · Received September 19, 2006

    Report

    Report Number
    9610483-2006-00212
    Event Type
    Other
    Date Received
    September 19, 2006
    Report Date
    August 11, 2003
    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 LSR IN QUESTION WAS NOT RETURNED FOR EVALUATION. A LAERDAL REPRESENTATIVE ATTENDED A MEETING AT THE HOSPITAL FOR DISCUSSION OF THE INCIDENT. IT WAS THERE REPORTED THAT THE DISC MEMBRANE (540105) HAD BEEN PLACED IN THE INTAKE VALVE IN PLACE OF THE INTAKE MEMBRANE (510404) WHICH HAD BEEN PLACED IN THE PATIENT VALVE WHERE THE DISC MEMBRANE (540105) SHOULD HAVE BEEN . AS MIS-ASSEMBLED, THE LSR WOULD FAIL TO ADEQUATELY VENTILATE THE PATIENT AND FAIL THE FUNCTION TESTING REQUIRED BY THE LSR OPERATING INSTRUCTIONS. IT WAS REVEALED THAT THE HOSPITAL HAD NO PROTOCOL IN PLACE TO PERFORM FUNCTION TESTING AND THE LSR IN QUESTION WAS NOT FUNCTION TESTED PRIOR TO USE IN THIS INCIDENT. IT WAS ALSO NOTED THAT THE HOSPITAL PRODUCED A DEPLOYED LSR FOR DEMONSTRATION OF THE FUNCTION TESTING AND IT FAILED DUE TO MIS-ASSEMBLY AND IT CONTAINED NON-LAERDAL COMPONENTS. THE LSR DIRECTIONS FOR USE ILLUSTRATES REASSEMBNLY OF THE DEVICE WITH LABELED COMPONENTS AND DFIRECTS USERS TO THE FUNCTION TESTING THAT CONFIRMS PROPER REASSEMBNLY IF PERFORMED. LAERDAL RECOMMENDED THE HOSPITAL BE PROVIDED WITH INTENSIVE IN-SERVICE EDUCATION ADDRESSING ALL ASPECTS OF APPLICATION AND DEPLOYMENT OF THE LSR IN PT CARE ENVIRONMENTS, BE PROVIDED WITH A QUANTITY OF LSR ASSEMBLY CHARTS, GUIDES AND DFUS, CONDUCT AN AUDIT OF ALL HOSPITAL RESUSCITATORS TO ASSURE HYBRID PARTS ARE NOT USED OR INTERCHANGED DURING MAINTENANCE, DECONTAMINATION AND REASSEMBLY OF THE LSR, AND IMPLEMENT FUNCTION TESTING.

    Description of Event or Problem · 1

    DURING AN INCIDENT IN A HOSPITAL, ON AN UNKNOWN DATE INVOLVING A PATIENT IN CARDIAC ARREST WHO HAD PRESENTED WITH ACUTE SHORTNESS OF BREATH FROM SEVERE PNEUMONIA, MULTIPLE CO-MORBIDITES AND ANGINA, AND REQUIRED INTUBATION AND VENTILATION, THIS LAERDAL SILICONE RESUSCITATOR (LSR) WAS USED FOR APPROXIMATELY 2 MINUTES BEFORE IT WAS REALIZED THAT THE LSR WAS NOT WORKING PROPERLY. MOUTH TO TUBE WAS BEGUN UNTIL ANOTHER LSR WAS SECURED. THE PATIENT WAS TRANSFERRED TO THE ICU BUT DIED THE SAME DAY. THE USER CLAIMED IT TOOK 2 MINUTES TO NOTICE THE LSR WAS MIS-ASSEMBLED (AS THE RESERVOIR BAG STILL VENTILATED) AND IT WAS NOT VISIBLE THAT A SMALL VALVE HAD BEEN PLACED IN THE RESERVOIR BAG END INSTEAD OF A LARGE VALVE.

    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 UNKNOWN Other