BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SALTER LABS

    MDR report key: 11825965 · Received May 14, 2021

    Report

    Report Number
    3000219639-2021-00011
    Event Type
    Injury
    Date Received
    May 14, 2021
    Date of Event
    May 7, 2021
    Report Date
    May 14, 2021
    Manufacturer
    SALTER LABS
    Product Code
    CCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    A FORMAL INVESTIGATION COULD NOT BE PERFORMED WITHOUT RETURNED PRODUCT. THE MOST LIKELY ROOT CAUSE OF THIS FAILURE IS A 2-BATTERY AND SPACER CONFIGURATION RATHER THAN A 3-BATTERY CONFIGURATION. IN FEB-2020, THE INTUBRITE PEDIATRIC HANDLES SWITCHED FROM 2-BATTERIES TO 3-BATTERIES, IN ORDER TO IMPROVE THE SHELF LIFE AND PERFORMANCE OF THE HANDLES. COMPLAINT HISTORY FOR THIS PART NUMBER WAS REVIEWED FOR THE LAST 24 MONTHS. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED AND THIS ISSUE DOES NOT APPEAR TO BE TRENDING, BUT WILL CONTINUE TO BE MONITORED. THIS IS A KNOWN ISSUE WITH OTHER PART NUMBERS, AND IT IS BEING TRACKED. CUSTOMER FOLLOW UP WAS PERFORMED VIA EMAIL, EXPLAINING THE MOST LIKELY ROOT CAUSE, THE ONGOING IMPROVEMENT PROJECT PERTAINING TO THIS ISSUE, AND THE COMPLAINT HISTORY FOR THIS PART NUMBER. RA: THIS FAILURE MODE (R8) IS IDENTIFIED ON THE RISK ANALYSIS FILE (RA-44). THE SEVERITY OF HARM FOR THIS FAILURE MODE IS CONSIDERED A MODERATE (4) RISK AND DOES NOT MEET THE THRESHOLD FOR CARB REVIEW (8).

    Description of Event or Problem · 0

    LAST NIGHT THEY TRIED TO USE ONE AND IT WAS VERY DIFFICULT TO SNAP TOGETHER AND WHEN I TRIED IT THIS MORNING THE LIGHT DID NOT WORK. I DID GRAB ANOTHER BLADE & HANDLE TO SEE WHICH WAS DEFECTIVE AND IT WAS THE HANDLE.

    Additional Manufacturer Narrative · 1

    THE DEFECT CAUSED THE PATIENT TO HAVE A DELAY IN THE INTUBATION PROCEDURE. THERE WAS NO PATIENT INJURY, THIS INCIDENT WILL BE REPORTED. ONE HANDLE HAD VERY DIM LIGHTING AND ANOTHER HAD NO LIGHT AT ALL. THE BLADES AND HANDLES WERE DETERMINED TO BE THE ISSUE FOR THE DELAYED INTUBATION IN A CRITICAL SITUATION. LOW ILLUMINATION MAY DELAY INTUBATION'S OR INCREASE THE NUMBER OF FAILED ATTEMPTS. STANDARD PRACTICE IS THAT A LARYNGOSCOPE BE CHECKED FOR PROPER ILLUMINATION PRIOR INTUBATION. LIMITED OR NO ILLUMINATION COULD COMPROMISE INTUBATION OR FIRST PASS SUCCESS RATE. BASED ON THE REPORTED INFORMATION AND THE EVENT ORIGINATING IN THE US, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.

    Description of Event or Problem · 1

    LAST NIGHT THEY TRIED TO USE ONE AND IT WAS VERY DIFFICULT TO SNAP TOGETHER AND WHEN I TRIED IT THIS MORNING THE LIGHT DID NOT WORK. I DID GRAB ANOTHER BLADE & HANDLE TO SEE WHICH WAS DEFECTIVE AND IT WAS THE HANDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720911 SALTER LABS BX20 - PEDIATRIC DISPOSABLE HANDLE 2/BATTERY CCW SALTER LABS 2016.C 070519ADPS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other