BEUDAMED
    FDA Adverse Event Other Summary report: N

    RSP LARYNG HANDLE 176336, PEDI RSP DISP LARYNG BLADE, 17660,

    MDR report key: 79281 · Received March 17, 1997

    Report

    Report Number
    2020364-1997-00007
    Event Type
    Other
    Date Received
    March 17, 1997
    Date of Event
    January 25, 1997
    Report Date
    March 6, 1997
    Manufacturer
    ORIGINAL MFR ANESTHESIA MEDICAL SPCLTS
    Product Code
    EQN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE RISK MANAGER STATED, "PARAMEDICS EXPERIENCED EQUIPMENT FAILURE WITH A LARYNGOSCOPE HANDLE WHEREBY LIGHTING WENT OUT EVERYTIME AND PRESSURE WAS APPLIED WHILE TRYING TO INTUBATE AN INFANT WITH SUSPECTED SIDS (SUDDEN INFANT DEATH SYNDROME). THE PT ULTIMATELY DIED AT EMERGENCY ROOM OF ANOTHER HOSP. THE PT WAS VENTILATED WITH A BAG VALVE MASK SYSTEM SINCE PARAMEDIS WERE UNABLE TO INTUBATE. LATER THE LIGHTING PROBLEM WAS REPRODUCIBLE WITH THE SAME HANDLE AND BLADE BUT NOT WITH OTHER BLADES WHEN PLACED ON THE SAME HANDLE. THERE HAVE NOT BEEN ANY PROBLEMS WITH THIS DISPOSABLE LARYNGOSCOPE BLADE IN THE PAST." CO MADE THREE ATTEMPTS TO OBTAIN ADD'L INFO" 1) DID PARAMEDICS TRY A SECOND TIME TO INTUBATE THE PT; 2) ARE DISPOSABLE BLADES REUSED; 3) WAS THE INFANT INTUBATED AT THE HOSP AND 4) ARE REUSABLE BLADES CARRIED IN THE PARAMEDIC VEHICLES. THESE ATTEMPTS WERE UNSUCCESSFUL. THERE IS NO CAUSAL CONNECTION BETWEEN INTERMITTENT LIGHTING OF THE LARYNGOSCOPE HANDLE AND THE DEATH OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP LARYNG HANDLE 176336, PEDI RSP DISP LARYNG BLADE, 17660, LARYNG HANDLE, 17636, PED DISP LARYNG BLADE, 17660, MIL 0 EQN ORIGINAL MFR ANESTHESIA MEDICAL SPCLTS 17636, 17660 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DAY Other