BEUDAMED
    FDA Adverse Event Other Summary report: N

    OHMEDA PEDIATRIC AEROSOL TENT

    MDR report key: 182157 · Received August 13, 1998

    Report

    Report Number
    1121732-1998-00007
    Event Type
    Other
    Date Received
    August 13, 1998
    Date of Event
    February 16, 1998
    Report Date
    July 24, 1998
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    BYK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN AN OHMEDA TELEMARKETER WAS TALKING TO A HOSPITAL EMPLOYEE (IN JULY 1998) ABOUT PURCHASING NEW EQUIPMENT, IT WAS REPORTED THAT THERE HAD BEEN AN INCIDENT IN FEBRUARY 1998 ON AN OHMEDA PEDIATRIC AEROSOL TENT. NO DETAILS WERE AVAILABLE AT THAT TIME. THE RISK MRG OF THE HOSPITAL WAS THEN CONTACTED FOR ADDITIONAL INFORMATION, AND STATED THAT A 5 MONTH OLD, LARGE, ACTIVE INFANT WAS TREATED IN THE TENT WITH HIS/HER PARENTS IN THE ROOM, AND WAS FOUND WRAPPED IN THE PLASTIC CANOPY. NO INJURY WAS SUSTAINED. THE RISK MRG STATED THAT THE HOSPITAL HAD EVALUTED THE EQUIPMENT AND IT WAS FOUND TO BE COMPLETELY FUNCTIONAL WITH NO PROBLEMS. SHE ALSO SAID THAT THE HOSPITAL DETERMINED THAT THE INCIDENT WAS PROBABLY THE RESULT OF THE PARENTS UNTUCKING THE CANOPY FROM THE MATTRESS, ALTHOUGH IT WAS DESIGNED TO BE TUCKED UNDERNEATH THE MATTRESS. ADDITIONAL DETAILS WERE REQUESTED BUT NO RESPONSE HAS BEEN REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA PEDIATRIC AEROSOL TENT PEDIATRIC AEROSOL TENT BYK OHMEDA MEDICAL UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Life Threatening