BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANDA IRES WARMER

    MDR report key: 15846310 · Received November 22, 2022

    Report

    Report Number
    2112667-2022-04937
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Date of Event
    October 26, 2022
    Report Date
    December 20, 2022
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    FMT
    PMA / PMN Number
    K122267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GE HEALTHCARE SERVICE REPRESENTATIVE PERFORMED A CHECKOUT OF THE SYSTEM AND CONFIRMED THE REPORTED ISSUE. THE FOOT PANEL WAS ORDERED FOR REPLACEMENT TO RESOLVE THE ISSUE. NO REPORT OF PATIENT INVOLVEMENT. LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PANDA NON-ROTATING BED WAS THE PART THAT WAS BROKEN. DAMAGE TO THIS PART IS NOT REPORTABLE. H3 OTHER TEXT : ADDITIONAL INFORMATION WAS RECEIVED THAT THE PANDA NON-ROTATING BED WAS THE PART THAT WAS BROKEN. DAMAGE TO THIS PART IS NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE UNIT HAD A BROKEN FOOT PANEL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353522 PANDA IRES WARMER WARMER, INFANT RADIANT FMT DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown