BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 .5V RCHG HANDLE F/DESK CHGR

    MDR report key: 17787977 · Received September 21, 2023

    Report

    Report Number
    1316463-2023-00207
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    August 9, 2023
    Report Date
    September 21, 2023
    Manufacturer
    WELCH ALLYN INC.
    Product Code
    HLJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE WELCH ALLYN PANOPTIC OPHTHALMOSCOPES ARE INTENDED TO BE USED BY CLINICIANS AND MEDICALLY QUALIFIED PERSONNEL FOR EXAMINATION OF THE RETINA, CORNEA, AQUEOUS, LENS AND VITREOUS OF THE EYE UNDER ILLUMINATION AND MAGNIFICATION ON PEDIATRIC AND ADULT PATIENTS. THE INTENDED USE ENVIRONMENTS FOR THE WELCH ALLYN PANOPTIC OPHTHALMOSCOPES ARE PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENTS SUCH AS GENERAL PHYSICIAN'S OFFICES, HOSPITALS, SPECIALIST, URGENT CARE, CLINICS, AND CLINICAL ENVIRONMENT TRAINING. THE PART NUMBER ASSOCIATED WITH THE WELCH ALLYN 3.5 V RECHARGEABLE POWER HANDLE FOR DESK CHARGER; LITHIUM- ION BATTERY IS # 71960. THE CUSTOMER DECLINED TO RETURN THE DEVICE FOR INSPECTION, THEREFORE AN INVESTIGATION INTO THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE PERFORMED. ALTHOUGH THERE WAS NO INJURY REPORTED, IF THE REPORTED EVENT WERE TO RECUR AND THE DEVICE WERE TO SPARK AND PRODUCE A FLAME, IT COULD LEAD TO A SERIOUS INJURY OR DEATH. THEREFORE, HILLROM IS REPORTING THIS MALFUNCTION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE OPHTHALMOSCOPE HANDLE WAS HOT AND PRODUCED SPARKS AND A SMALL FLAME WHEN THE UNIT WAS SWITCHED ON. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518780 3 .5V RCHG HANDLE F/DESK CHGR OPHTHALMOSCOPE, BATTERY-POWERED HLJ WELCH ALLYN INC. 71670

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown