BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE2000

    MDR report key: 17872692 · Received October 4, 2023

    Report

    Report Number
    1316463-2023-00224
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 8, 2023
    Report Date
    June 11, 2024
    Manufacturer
    WELCH ALLYN INC
    Product Code
    NOU
    UDI-DI
    00887761978201
    PMA / PMN Number
    K170037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS A CORRECTION TO THE PREVIOUSLY SUBMITTED MDR. FOLLOWING COMMUNICATION FROM THE FDA REGARDING INCORRECT/MISSING UDI NUMBERS, BAXTER REVIEWED THE SUBJECT MDR AND DETERMINED BRAND NAME, PRODUCT CODE, AND UDI CORRECTIONS WERE REQUIRED TO THIS MDR IN ALIGNMENT WITH THE GUDID.

    Additional Manufacturer Narrative · 0

    THE HILLROM TECHNICIAN FOUND THE POWER CORD NEEDED TO BE REPLACED. THE BREATHE TECHNOLOGIES LIFE2000® VENTILATION SYSTEM IS INTENDED TO PROVIDE CONTINUOUS OR INTERMITTENT VENTILATORY SUPPORT FOR THE CARE OF INDIVIDUALS WHO REQUIRE MECHANICAL VENTILATION. SPECIFICALLY, THE SYSTEM IS APPLICABLE FOR ADULT PATIENTS WHO REQUIRE THE FOLLOWING TYPES OF VENTILATORY SUPPORT: POSITIVE PRESSURE VENTILATION, DELIVERED INVASIVELY (VIA ET TUBE) OR NON-INVASIVELY (VIA MASK). ASSIST/CONTROL MODE OF VENTILATION. A SEARCH OF THE HILLROM MAINTENANCE RECORDS DID NOT SHOW HILLROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. A POWER CORD WAS SHIPPED OVERNIGHT TO BE REPLACED AND RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE POWER CORD WAS DAMAGED WITH VISIBLE COPPER WIRES. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE POWER CORD WAS DAMAGED WITH VISIBLE COPPER WIRES. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200731 LIFE2000 CONTINUOUS, VENTILATOR, HOME USE NOU WELCH ALLYN INC BT-20-0002 00887761978201
    2014319 LIFE2000 CONTINUOUS, VENTILATOR, HOME USE NOU WELCH ALLYN INC BT-20-0002 00887761978201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown