BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANDA

    MDR report key: 21303032 · Received February 4, 2025

    Report

    Report Number
    21303032
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    December 6, 2024
    Report Date
    February 2, 2025
    Manufacturer
    DATEX-OHMEDA ,INC
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ERROR WITH PANDA INFANT WARMER SCALE: BIRTH WEIGHT (WT) FOR NEWBORN WAS RECORDED AS [REDACTED]G USING WARMER. FOR THE DAILY WT ON NIGHTS USING INFANT SCALE IN NBN, WT FOUND TO BE [REDACTED]G. THIS WOULD BE A 23% CHANGE. THE NEXT DAY, HAD BIOMED COME AND CHECK THE WARMER, AND IT WAS FOUND TO BE WEIGHING INCORRECTLY, SO REMOVED FROM SERVICE FOR REPAIR. AFTER DISCUSSION WITH PEDIATRICIAN, DECISION MADE TO DELETE ORIGINAL BIRTH WT AND USE THE 1ST ACCURATE WT AS BIRTH WT. BEDSIDE NURSE AND MOTHER UPDATED AD HOC FOR BIRTH CERTIFICATE. MANUFACTURER RESPONSE FOR INFANT WARMER, (BRAND NOT PROVIDED) (PER SITE REPORTER). BUT SINCE THIS IS AN OPEN CLARITY I CALLED GE FOR TECH SUPPORT. WE DID SOME TROUBLESHOOTING AND HE INFORMED ME THAT IT COULD BE A LOAD CELL MALFUNCTION OR A MECHANICAL ISSUE LIKE THE RUBBER SHOCKS ON BOTTOM OF SCALE. HE HAD ME GO INTO SERVICE MODE AND PERFORM AN OFF-CENTER TEST AND IT FAILED, AS SOME CORNERS WERE OFF SIGNIFICANTLY. HIS RECOMMENDATION IS TO REPLACE THE LOAD CELL AND SHOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64018 PANDA WARMER, INFANT RADIANT FMT DATEX-OHMEDA ,INC PANDA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown