BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PANDA IRES WARMER

    MDR report key: 19668322 · Received July 3, 2024

    Report

    Report Number
    2112667-2024-03538
    Event Type
    Injury
    Date Received
    July 3, 2024
    Date of Event
    November 20, 2018
    Report Date
    July 3, 2024
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    FMT
    PMA / PMN Number
    K201628
    Removal / Correction Number
    Z-1846-2019 & Z-1847-201
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806 ON 20 MARCH 2019. THE FDA RECALL NUMBER IS Z-1846-2019 & Z-1847-2019. - CUSTOMERS WERE SENT A LETTER EXPLAINING THE ISSUE AND REQUESTING THE CUSTOMER TO INSPECT THE WARMER BEDSIDE PANEL LATCH AREAS. REPLACEMENT OF BROKEN BEDSIDE PANELS WAS PROVIDED BY GEHC. - A SET OF WARNING LABELS WAS SUPPLIED FOR APPLICATION TO THE BEDSIDE PANELS. THESE LABELS WARN THE USER TO NOT USE THE BEDSIDE PANELS FOR MANEUVERING THE WARMER AND INDICATE THE CORRECT METHOD OF MANEUVERING THE WARMER. - AN ADDENDUM TO THE OPERATION AND MAINTENANCE MANUAL WAS PROVIDED EMPHASIZING THE NEED TO CHECK AND ENSURE THAT THE BEDSIDE PANELS AND LATCHES ARE NOT CRACKED, BROKEN, OR DAMAGED BEFORE EVERY PATIENT USE. THE ADDENDUM CONTAINED INSTRUCTIONS TO INCREASE DETECTABILITY OF BROKEN OR CRACKED BEDSIDE PANELS. - ON JUNE 14, 2019 A LETTER WAS SENT TO CUSTOMERS PROVIDING AN ADDITIONAL ADDENDUM, LABELS, AND WALL POSTER. D4 SERIAL NUMBER: NOT PROVIDED.. SECTION E: INITIAL REPORTER / CONTACT INFORMATION NOT PROVIDED. G2 REPORT SOURCE OTHER: MAUDE DATA BASE REPORT # (B)(4). H4 DATE OF DEVICE MANUFACTURE: UNKNOWN AS THE SERIAL NUMBER WAS NOT PROVIDED. LEGAL MANUFACTURER: HCS RESEARCH PARK - 9900 INNOVATION DRIVE USA WAUWATOSA, WI 53226.

    Description of Event or Problem · 0

    PER MAUDE DATA BASE REPORT # (B)(4): "PLASTIC HINGE AT FOOT OF PANDA WARMER CRACKED AND RESULTED IN A FAILURE OF THE END PLASTIC PANELS. THE END PANEL OPENED DUE TO THE CRACKED PLASTIC AND INFANT FELL TO FLOOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959353 PANDA IRES WARMER WARMER, INFANT RADIANT FMT DATEX-OHMEDA, INC. M1112198

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Unknown Hospitalization