BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINTLER PATIENT WARMING SYSTEM

    MDR report key: 20203616 · Received September 12, 2024

    Report

    Report Number
    20203616
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    July 19, 2024
    Report Date
    August 19, 2024
    Manufacturer
    CDR MANUFACTURING, INC., DBA KEYTRONIC
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PINTLER WARMING MATTRESS LOT # 18775 AND PINTLER CONTROL UNIT. THE WARMING MATTRESS WAS ON TOP OF THE OR (OPERATING ROOM) TABLE WITH PATIENT (PT). SURGERY TOOK PLACE. POSTOP CLEANING OF THE SURGICAL TABLE FOUND A SCORCHED MATTRESS & SHEET WITH NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506027 PINTLER PATIENT WARMING SYSTEM SYSTEM, THERMAL REGULATING DWJ CDR MANUFACTURING, INC., DBA KEYTRONIC 18775

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Female