BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE PATIENT PROBE

    MDR report key: 2428635 · Received January 23, 2012

    Report

    Report Number
    1121732-2012-00001
    Event Type
    Injury
    Date Received
    January 23, 2012
    Date of Event
    November 22, 2011
    Report Date
    December 29, 2011
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMZ
    PMA / PMN Number
    K010222
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE 510 (K) NUMBER PROVIDED IS FOR THE GIRAFFE INCUBATOR. THE TEMPERATURE PROBE DOES NOT HAVE ITS OWN 510 (K) NUMBER. THERE ARE MULTIPLE PROBES INVOLVED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME INFANTS SHOWED CLINICAL SIGNS OF DEHYDRATION REQUIRING MEDICAL INTERVENTION FOR ELECTROLYTE AND UREA IMBALANCE. THE NURSING STAFF WAS REPORTEDLY NOT USING THE RECOMMENDED REFLECTIVE PATCHES WITH THE GIRAFFE SKIN TEMPERATURE PROBES AND WERE WITHDRAWING HUMIDITY THERAPY WITHIN THE GIRAFFE INCUBATOR AT AN ACCELERATED RATE DUE TO INACCURATE SKIN TEMPERATURE READINGS. THE TEMPERATURE PROBES WERE REPORTEDLY NOT PROPERLY ADHERED TO THE INFANTS' SKIN WHICH MAY HAVE BEEN A FACTOR IN THE INACCURATE SKIN TEMPERATURE READINGS. THERE WAS NO PERMANENT INJURY OR DEATH REPORTED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE PATIENT PROBE TEMPERATURE PROBE FMZ OHMEDA MEDICAL GDPPM0601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention