BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANDA IRES WARMER

    MDR report key: 10629288 · Received October 5, 2020

    Report

    Report Number
    2112667-2020-02762
    Event Type
    Malfunction
    Date Received
    October 5, 2020
    Date of Event
    September 8, 2020
    Report Date
    October 5, 2020
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    FMT
    PMA / PMN Number
    K122267
    Removal / Correction Number
    SEEH10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO REPORT OF PATIENT INVOLVEMENT. 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 WILL BE PROVIDED BY GEHC. A SET OF WARNING LABELS WILL BE SUPPLIED FOR APPLICATION TO THE BEDSIDE PANELS. THESE LABELS WILL 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 WILL ALSO BE 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 WILL ALSO CONTAIN 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. NO REPORT OF PATIENT INVOLVEMENT. 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.

    Description of Event or Problem · 1

    AS A RESULT OF AN INSPECTION THAT WAS COMPLETED AS PART OF CORRECTION AND REMOVAL Z-1846-2019 & Z-1847-2019, THIS SYSTEM WAS IDENTIFIED AS HAVING THE BROKEN LATCH, AND/OR CRACKED WALL MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089564 PANDA IRES WARMER WARMER, INFANT RADIANT FMT DATEX-OHMEDA, INC. M1112198

    Patients

    Seq Age Sex Outcome Treatment
    1