BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT WARMING SYSTEM M1000 CONTROL UNIT

    MDR report key: 15329012 · Received August 31, 2022

    Report

    Report Number
    3014421917-2022-00001
    Event Type
    Injury
    Date Received
    August 31, 2022
    Date of Event
    March 18, 2022
    Report Date
    February 17, 2023
    Manufacturer
    O&M HALYARD. INC.
    Product Code
    DWJ
    PMA / PMN Number
    K033021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE FOR RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. ALL INFORMATION REASONABLY KNOWN AS OF 31AUG2022 HAS BEEN INCLUDED IN THIS MEDICAL DEVICE REPORT. THE INFORMATION PROVIDED BY O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. O&M HALYARD, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS SENT TO NORTECH (THE DEVICE SERVICER) WHERE CALIBRATION, FUNCTIONAL, AND SAFETY TESTS WERE PERFORMED. THE DEVICES PASSED ALL TESTS AND NORTECH WAS NOT ABLE TO DUPLICATE THE CUSTOMER EXPERIENCE. WE WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS PRODUCT. ALL INFORMATION REASONABLY KNOWN AS OF 15FEB2023 HAS BEEN INCLUDED IN THIS MEDICAL DEVICE REPORT. THE INFORMATION PROVIDED BY O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. O&M HALYARD, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    PATIENT 1 OF 2. A FDA MEDWATCH REPORT 5111003 WAS RECEIVED 04AUG2022. THE REPORT STATES THAT THERE WERE TWO PATIENTS THAT HAD SECOND DEGREE BURNS TO THEIR BACKS WHICH INCREASED THEIR HOSPITAL STAY. THIS HOSPITAL WAS USING A KIMBERLY-CLARK INTRAOPERATIVE WARMING SYSTEM M1000 (MADE BY O&M HALYARD, INC.) DURING CARDIAC SURGERY STARTING JUNE 2022. THE GEL PADS ARE APPLIED TO THE BACK WITH A WARMING CONSOLE THAT HAS WATER. A JOINT PATIENT SAFETY REPORT WAS DONE ON BOTH CASES. ONE PATIENT REQUIRED WOUND CARE SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2469100 PATIENT WARMING SYSTEM M1000 CONTROL UNIT TEMPERATURE MANAGEMENT PRODUCTS DWJ O&M HALYARD. INC. 01000-01 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention