BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAC PAC SIZE 30

    MDR report key: 22926697 · Received August 29, 2025

    Report

    Report Number
    9612330-2025-00017
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    June 16, 2025
    Report Date
    September 18, 2025
    Manufacturer
    NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD.
    Product Code
    CCX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REFERENCE NATUS COMPLAINT# (B)(4). ADDITIONAL INFORMATION ADDED TO THE BELOW SECTIONS WITH REFERENCE TO RELATED REPORT# MW5174570 RECEIVED 17 SEPT 2025. SECTION A2, SECTION A3A - PATIENT INFORMATION. SECTION B3 - DATE OF EVENT. SECTION H6 - HEALTH EFFECTS CODES. SECTION H10 - ADDED REFERECE TO RELATED REPORT NUMBER - MW5174570.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REFERENCE NATUS COMPLAINT#: (B)(4). INSTALL DATE: ON (B)(6) 2017. PER DOC-040662 REV E VAC-PAC RISK ANALYSIS, HAZARD ID: 13.1, HAZARD SITUATION: VAC-PAC PAD IS NOT USED AS INTENDED, HARM: POTENTIAL INDIRECT PATIENT INJURY, CAUSE: USER DOESN'T HAVE SUFFICIENT KNOWLEDGE ABOUT THE PRODUCT, SEVERITY: LOW. THIS CUSTOMER USED THE VAC-PAC ON A PATIENT USING A WARMING SOURCE MOST LIKELY UNDER THE PATIENT FOR SEVERAL HOURS, WHICH CONTRIBUTED TO THE PATIENT RECEIVING A 2ND DEGREE BURN. THE VAC-PAC DID NOT MALFUNCTION. THE VAC PAC USER MANUAL (031817-EN REV D) STATES, "HIGH TEMPERATURES WILL DAMAGE THE VAC-PAC; NEVER STEAM AUTOCLAVE VAC-PACS" AND LISTS THE OPERATING TEMPERATURE AS "18 °C TO 29 ° CELSIUS". HISTORY OF COMPLAINTS WAS REVIEWED AND IT IS NOTED THAT THIS IS THE FIRST TIME A PATIENT RECEIVED A BURN WHILE THE VAC-PAC WAS IN USE. NO RELATED CAPAS. INVESTIGATION RESULT CODE: NEURO SBU/USER ERROR.

    Description of Event or Problem · 0

    VAC PAC SIZE 30 - THE CUSTOMER REPORTED THAT THE PATIENT ENDURED 2ND DEGREE BURNS WHILE USING THE VACPAC. THE CUSTOMER STATED THAT THE VACPAC WAS UNDER THE DRAPES AND HEATED UP, AND THAT THE HEAT SOURCE WAS LIKELY AN UNDER-BODY FLUID BED WARMING BLANKET. THE CUSTOMER STATES HE BELIEVES THE WARMING SOURCE HEATED UP THE VAC PAC UNDER THE DRAPES AND OVER SEVERAL HOURS THE VAC PAC BECAME HOT ENOUGH TO CONTRIBUTE TO THE BURN THIS PATIENT RECEIVED.

    Description of Event or Problem · 0

    VAC PAC SIZE 30 - THE CUSTOMER REPORTED THAT THE PATIENT ENDURED 2ND DEGREE BURNS WHILE USING THE VACPAC. THE CUSTOMER STATED THAT THE VACPAC WAS UNDER THE DRAPES AND HEATED UP, AND THAT THE HEAT SOURCE WAS LIKELY AN UNDER-BODY FLUID BED WARMING BLANKET. THE CUSTOMER STATES HE BELIEVES THE WARMING SOURCE HEATED UP THE VAC PAC UNDER THE DRAPES AND OVER SEVERAL HOURS THE VAC PAC BECAME HOT ENOUGH TO CONTRIBUTE TO THE BURN THIS PATIENT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2879950 VAC PAC SIZE 30 VAC PAC SIZE 30 CCX NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. 51630 N042117-08

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male Other