BEUDAMED
    FDA Adverse Event Other Summary report: N

    AIR-SHIELDS VICKERS

    MDR report key: 104148 · Received June 30, 1997

    Report

    Report Number
    104148
    Event Type
    Other
    Date Received
    June 30, 1997
    Date of Event
    May 9, 1997
    Report Date
    May 14, 1997
    Manufacturer
    *
    Product Code
    FMT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFANT WARMER MALFUNCTION-COULDN'T REGULATE. TEMPERATURE FLUCTUATED UP AND DOWN SEVERAL DEGREES FROM SET POINT OF 37 DEGREES. 05/09/97 2030 T.37. CYANOTIC. NO RESPIRATION STIMULATED WITH SUCTION. O2 PER MASK. NO RESP X 20 - 40 SECONDS. DOCTOR NOTIFIED. HEART/APNEA MONITOR ORDERED. INFANT'S TEMP AT 2215 ON 05/09/97 WAS 38.5. PULSE OX SHOWED 89-91%. PHYSICIAN NOTIFIED RESULTING IN NEW ORDERS. WARMER CHECKED. INFANT TRANSFERRED TO A DIFFERENT WARMER. PHYSICIAN PROGRESS NOTES STATES "CHOKING SPELLS WITH FEEDING-ONE ACCOMPANIED WITH APNEA SPELL. ERRONEOUS TEMP READING LAST NIGHT DUE TO WARMER. MONITOR FOR AN EXTRA DAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIR-SHIELDS VICKERS INFANT WARMER FMT * PM 78-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Other ANTIBIOTICS| CBC| CBC| HEART /APNEA MONITOR| TYLENOL| BLOOD CULTURES