BEUDAMED
    FDA Adverse Event Death Summary report: N

    SALTER LABS

    MDR report key: 15998565 · Received December 16, 2022

    Report

    Report Number
    3000219639-2022-00042
    Event Type
    Death
    Date Received
    December 16, 2022
    Date of Event
    November 3, 2022
    Report Date
    December 16, 2022
    Manufacturer
    SALTER LABS
    Product Code
    CBI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERRUPTION IN THERAPY CAUSED THE PATIENT TO BE RE-INTUBATED. THE IFU INSTRUCTS USERS THAT LONG-TERM USE, MORE THAN 24-48 HOURS SHOULD APPROACH WITH CAUTION BECAUSE IT INCREASES THE RISK FOR PARTIAL OR COMPLETE OCCLUSION. EVEN THOUGH THE ISSUE STATES THE PATIENT EXPIRED IT WAS STATED IT WAS NOT DUE TO THE MALFUNCTION OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    INTERRUPTION IN THERAPY CAUSED THE PATIENT TO BE RE-INTUBATED. THE IFU INSTRUCTS USERS THAT LONG-TERM USE, MORE THAN 24-48 HOURS SHOULD APPROACH WITH CAUTION BECAUSE IT INCREASES THE RISK FOR PARTIAL OR COMPLETE OCCLUSION. EVEN THOUGH THE ISSUE STATES THE PATIENT EXPIRED IT WAS STATED IT WAS NOT DUE TO THE MALFUNCTION OF THE DEVICE DID NOT CONFIRM COMPLAINT DUE TO LACK OF PHOTO OR RETURN. SENT AND RECEIVED ROOT CAUSE INVESTIGATION TO THE SUPPLIER. REVIEWED COMPLAINT HISTORY FOR THE 24 MONTHS PRECEDING THE COMPLAINT REPORTING DATE AND THERE WERE ONLY 2 COMPLAINTS FOR THIS PART NUMBER. THERE IS NO TRENDING ISSUE. PERFORMED RISK ANALYSIS AND DETERMINED A SEVERITY RATING OF 6. SENT A RESOLUTION WITH ROOT CAUSE INVESTIGATION RESULTS TO THE CUSTOMER.

    Description of Event or Problem · 0

    CUFF WAS BLOWN, HAD TO REINTUBATE. EMERGENT INTUBATION, AFTER CODE WAS COMPLETED STAFF NOTED CUFF WAS BLOWN, HAD TO RE-INTUBATE, CODE WAS CALLED. PATIENT EXPIRED NOT RELATED TO EQUIPMENT. TUBE WAS 7.5, RE-INSERTED A 8.0...

    Description of Event or Problem · 0

    CUFF WAS BLOWN, HAD TO REINTUBATE. EMERGENT INTUBATION, AFTER CODE WAS COMPLETED STAFF NOTED CUFF WAS BLOWN, HAD TO RE-INTUBATE, CODE WAS CALLED. PATIENT EXPIRED. NOT RELATED TO EQUIPMENT. TUBE WAS 7.5, RE-INSERTED A 8.0

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2708905 SALTER LABS ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 7.5MM CBI SALTER LABS H-PFHV-75 2102HV0412

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| O