BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTER LABS

    MDR report key: 18843072 · Received March 5, 2024

    Report

    Report Number
    3000219639-2024-00028
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    February 6, 2024
    Report Date
    March 5, 2024
    Manufacturer
    SALTER LABS
    Product Code
    BYX
    UDI-DI
    00607411889097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT TRIPPED OVER THE OXYGEN TUBING, WAS INJURED. THE PATIENT INJURIES WERE UNKNOWN. THE OXYGEN TUBING CONTRIBUTED MAY HAVE CONTRIBUTED TO AN INJURY BUT DID NOT MALFUNCTION THE COMPLAINT INVESTIGATION WAS PERFORMED BASED ON THE CONTENT OF THE ISSUE REPORTED. THERE WERE NO PHOTO IMAGES OR VIDEOS PROVIDED FOR EVALUATION; THEREFORE, THE COMPLAINT IS UNABLE TO EVALUATE. NO LOT NUMBER WAS PROVIDED FOR DEVICE HISTORY RECORD (DHR) EVALUATION; THEREFORE, NO DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED. THE POTENTIAL ROOT CAUSE MAY HAVE BEEN DUE TO EXCESS TUBING LOOSELY COILED MAY HAVE BEEN PLACED IN THE WAY DURING THE PATIENT MOVEMENT. THE IFU FOR O2 TUBING STATES, 'KEEP EXCESS TUBING LOOSELY COILED OUT OF THE WAY TO PREVENT KINKING AND TRIPPING HAZARD.' THE COMPLAINT HISTORY WAS REVIEWED IN GRAND AVENUE FROM (B)(6) 2022, TO (B)(6) 2024, FOR PART NUMBER SO-1188 FOR FAILURE MODE "TRIPPING", THERE WERE ONE (1) COMPLAINT REPORTED FOR PART NUMBER SO-1188 FROM (B)(6) 2022, TO (B)(6) 2024, TIMEFRAME. THERE IS NO TREND FOR THIS PRODUCT REPORTED. BASED ON RMA-20017C, REV 6, OXYGEN TUBING AND ACCESSORIES, PRODUCT RISK ANALYSIS. UNDER THE KNOWN AND FORESEEABLE HAZARDS "TRIPPING" UNDER ID R77. THE POTENTIAL CAUSE(S) OF HAZARD (HAZARDOUS SITUATION) FOR TWISTED TUBING CAUSING FALL ARE 8 = SEVERITY, 3 = LIKELIHOOD OF OCCURRENCE, RPN = 24; THEREFORE, THE RISK LEVEL IS ACCEPTABLE. DUE TO THE LOW NUMBER OF REPORTED COMPLAINTS AND MEDIUM/HIGH SEVERITY THIS COMPLAINT HAS A MEDIUM RISK AS STATED IN RISK DETERMINATION CHART: REF-20001-C1 WHICH IS ALIGNED TO THE APPROVED RISK MANAGEMENT DOCUMENTATION. THE REGULATORY / COMPLIANCE RISK IS MEDIUM. WITH THE LOW-LEVEL COMPLAINTS ASSOCIATED WITH THIS PART NUMBER, AND THE OCCURRENCE RATE OF REMOTE, AN HHE SHOULD NOT BE CONSIDERED. WE WILL CONTINUE TO MONITOR TRENDS DURING OUR PERIODIC COMPLAINT REVIEW MEETINGS.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE PATIENT TRIPPED OVER THE OXYGEN TUBING, WAS INJURED. THE PATIENT INJURIES WERE UNKNOWN. THE OXYGEN TUBING CONTRIBUTED MAY HAVE CONTRIBUTED TO AN INJURY BUT DID NOT MALFUNCTION.

    Description of Event or Problem · 0

    PATIENT FELL AND CAUGHT HIS FEET IN THE TUBING.

    Description of Event or Problem · 0

    PATIENT FELL AND CAUGHT HIS FEET IN THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1656510 SALTER LABS PATIENT KIT - (1) #1215, AND (1) #2025 (AIR LIQUIDE BYX SALTER LABS SO-1188 UNKNOWN 00607411889097

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other