BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROSCOPE¿ 5210

    MDR report key: 14462996 · Received May 20, 2022

    Report

    Report Number
    2434008-2022-00001
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    May 11, 2022
    Report Date
    May 20, 2022
    Manufacturer
    AMERICAN DIAGNOSTIC CORPORATION
    Product Code
    HLJ
    UDI-DI
    00634782053413
    PMA / PMN Number
    K093495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADC RECEIVED A REPORT FROM OUR DISTRIBUTOR THAT A PRODUCT SOLD TO AN END USER FACILITY HAD PRESENTED ABNORMAL HEAT AND THEN CAUGHT FIRE. NO INJURIES OR PATIENT INVOLVEMENT WAS REPORTED. THE DEVICE INVOLVED IN THE INCIDENT WAS DISCARDED AND WAS NOT PROVIDED TO ADC. DUE TO THE FACT THAT THE INVOLVED DEVICE WAS DISCARDED, ADC HAS CONDUCTED TESTS ON EXISTING STOCK TO IDENTIFY ANY RISKS POSED BY THE DEVICE. THIS DEVICE IS A BATTERY HANDLE WITH DETACHABLE OTOSCOPE AND OPHTHALMOSCOPE HEAD ATTACHMENTS. IT IS HAND HELD, 2.5V AND USES TWO C CELL BATTERIES. THE DEVICE IS OPERATED WITH A RHEOSTATIC POWER CONTROL SWITCH. TO REPLICATE THE RISKS ASSOCIATED WITH THE CIRCUIT USED IN THE DEVICE ADC HAS CREATED FOUR TEST SAMPLES, WITH ONE SAMPLE BEING A CONTROL AND THREE SAMPLES BEING INTENTIONALLY SHORTED TO CREATE HEAT. IN ADDITION, TESTING WAS PERFORMED USING THE OPHTHALMOSCOPE HEAD ATTACHMENT WHICH PLACES THE BULB IN THE DEVICE AS CLOSE TO THE BATTERY HANDLE AS POSSIBLE, MAXIMIZING HEAT OUTPUT AND CREATING A WORST CASE SCENARIO. AS DEMONSTRATED IN THE ATTACHED REPORT, TESTING HAS SHOWN THAT EVEN IN A FAULT OR SHORTED CONDITION THIS PRODUCT CANNOT GENERATE ADEQUATE HEAT TO CREATE IGNITION OR PRESENT A HAZARD OF BURNS OR OTHER HEAT-RELATED INJURIES. THE PRODUCT WILL ALSO NOT CREATE ADEQUATE HEAT TO CREATE IGNITION WHEN LEFT ON FOR AN EXTENDED PERIOD OF TIME BEYOND THE NORMAL USE OF THE DEVICE OR WHEN LEFT POWERED ON IT IS CARRYING CASE. HISTORICAL DATA FOR THIS PRODUCT LINE WAS EVALUATED AND THIS PRODUCT CATEGORY HAS BEEN ON THE MARKET FOR MULTIPLE DECADES WITH NO PREVIOUSLY REPORTED FIRE EVENTS OR HAZARDS. WE HAVE CONCLUDED THAT THIS EVENT WOULD HAVE BEEN CAUSED BY EXTERNAL FACTORS SUCH AS AN EXTERNAL HEAT SOURCE OR BY THE USE OF BATTERIES INAPPROPRIATE FOR A 2.5V SYSTEM, SUCH A LITHIUM ION, LITHIUM METAL, OR RECHARGEABLE BATTERIES WITH AN INAPPROPRIATE VOLTAGE FOR THIS TYPE OF DEVICE. THIS DEVICE IS NOT SOLD WITH BATTERIES INCLUDED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT ADC'S PART NUMBER 5210, WHICH IS A 2.5V OTOSCOPE AND OPHTHALMOSCOPE, HAD ABNORMAL HEAT WHEN THEY ATTEMPTED TO USE IT AND THAT THE PRODUCT CAUGHT ON FIRE. NO INJURIES WERE REPORTED AND NO PATIENT INVOLVEMENT. THIS IS A HANDHELD, BATTERY OPERATED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658769 PROSCOPE¿ 5210 OTOSCOPE AND OPHTHALMOSCOPE HLJ AMERICAN DIAGNOSTIC CORPORATION 5210 102020354 00634782053413

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown