BEUDAMED
    FDA Adverse Event Other Summary report: N

    DISPOSABLE LARYNGOSCOPE SYSTEM

    MDR report key: 64333 · Received January 20, 1997

    Report

    Report Number
    2020364-1997-00001
    Event Type
    Other
    Date Received
    January 20, 1997
    Date of Event
    December 14, 1996
    Report Date
    January 20, 1997
    Manufacturer
    ORIGINAL MFR. ANESTHESIA MEDICAL SPCLTS.
    Product Code
    EQN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    "THE PT, A 90 YR OLD FEMALE, (WEIGHT UNREPORTED) WAS FOUND UNRESPONSIVE AND EXTREMITIES POSTURING, INDICATING A POSSIBLE CEREBRAL HEMORRHAGE(CVA). DURING A INTUBATION ATTEMPT, THE BLADE BROKE IN THREE PIECES (NEAR THE CONTACT AREA). THE BLADE WAS RETRIEVED AND THE SMALLER PIECES WERE STILL ON THE LARYNGOSCOPE HANDLE. THE BLADE WRAPPER WAS NOT SAVED AND THE BATCH NUMBER IS UNK. THE PARAMEDIC REVENTILATED THE PT AND ATTEMPTED (TO INTUBATE) A SECOND TIME. THE PT NEEDED SUCTIONING, AND DURING THE SUCTIONING, THE PT CLENCHED HER TEETH. (THIS IS) ANOTHER INDICATION OF A HEAD INJURY. THE PARAMEDIC WAS ABLE TO MAINTAIN AN AIRWAY BY SUCTIONING AND USING A BAG VALVE MASK. THE PT WAS SUCCESSFULLY INTUBATED AT THE HOSPITAL; HOWEVER, THE PT DIED THE NEXT DAY(12/15/96) DUE TO THE MASSIVE CEREBRAL HEMORRHAGE." STATED DIR OF HEALTH AND CLINICAL SERVICE, THERE IS NO CAUSAL CONNECTION BETWEEN THE BLADE BREAKING AND THE DEATH OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE LARYNGOSCOPE SYSTEM LARYNGOSCOPE BLADE, DISPOSABLE EQN ORIGINAL MFR. ANESTHESIA MEDICAL SPCLTS. MACINTOSH SIZE 4 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Other