BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAERDAL SILICONE RESUSCITATOR

    MDR report key: 811855 · Received January 11, 2007

    Report

    Report Number
    9610483-2006-00236
    Event Type
    Malfunction
    Date Received
    January 11, 2007
    Date of Event
    September 1, 2006
    Report Date
    December 12, 2006
    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) IN QUESTION WAS NOT RETURNED TO THE MFR FOR EVALUATION. IT WAS PUT BACK INTO SERVICE AT THE HOSPITAL. THE CUSTOMER ADMITS NOT ADHERING TO RECOMMENDED TESTING PROTOCOL AND HAVE UNDERTAKEN A RE-EDUCATION PROGRAM TO FULLY INFORM THEIR CLINICIANS OF THE IMPORTANCE OF THE FUNCTION TESTING THAT WOULD HAVE DETECTED THIS MIS-ASSEMBLY. THE REASSEMBLY INSTRUCTIONS OF THE LSR, AS SHOWN IN THE PARTS ILLUSTRATION IN THE DIRECTIONS FOR USE (DFU), VERY CLEARLY ILLUSTRATES THAT THE FLAP VALVE IS NOT PART OF THE PT VALVE, BUT RATHER IS PART OF THE INTAKE VALVE. ADDITIONALLY, THERE ARE CAUTIONS AND WARNINGS IN THE DFU DRAWING ATTENTION TO THE IMPORTANCE OF CORRECT REASSEMBLY OF THE PT VALVE AND STRESSING THAT IMPROPER ASSEMBLY MAY AFFECT PERFORMANCE OF THE LSR. THE STEP-BY-STEP FUNCTION TEST DESCRIBED IN THE DFU WOULD HAVE REVEALED THE MALFUNCTION OF THE LSR AND SHOULD HAVE BEEN PERFORMED PRIOR TO USE. IT IS CONCLUDED THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR REASSEMBLY OF THE LSR, AS DESCRIBED IN THE DFU, AND DID NOT PERFORM A FUNCTION TEST BEFORE USE. IT IS EXPECTED THAT THE INSTRUCTIONS IN THE DFU ARE FOLLOWED IN ORDER TO ENSURE A CORRECT ASSEMBLY/FUNCTION OF THE LSR.

    Description of Event or Problem · 1

    DURING TREATMENT AT A HOSPITAL INVOLVING A MALE INFANT WHO NEEDED ASSISTED VENTILATION OR RESUSCITATION, THIS LAERDAL SILICONE RESUSCITATOR (LSR) DID NOT FUNCTION AS INTENDED. THE BABY THEN UNDERWENT AN EMERGENCY PROCEDURE INCLUDING BRONCHOSCOPY, AS THE STAFF THOUGHT THE UNSUCCESSFUL VENTILATION WAS DUE TO AN AIRWAY PROBLEM. DURING THE BRONCHOSCOPY PROCESS, THE LSR PROBLEM WAS IDENTIFIED, AND THE BABY WAS THEN SUCCESSFULLY VENTILATED. THE HOSPITAL FOUND AN EXTRA FLAP VALVE INSTALLED IN THEIR LSR THAT WAS SITTING ON TOP OF THE LIP VALVE PREVENTING AIR FROM PASSING THROUGH. THE HOSPITAL'S LSRS ARE CLEANED AND PROCESSED BY THEIR CSSD, REASSEMBLED BY THEM AND CHECKED BY CLINICIANS PRIOR TO USE. THEY ADMITTED THAT THEY DO NOT PERFORM THE FUNCTION TEST DEFINED IN THE LSR DIRECTIONS FOR USE. THE LSR WAS RETURNED TO SERVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening