BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LED LOUPES LIGHT UNIT

    MDR report key: 8372044 · Received February 26, 2019

    Report

    Report Number
    2523190-2019-00026
    Event Type
    Malfunction
    Date Received
    February 26, 2019
    Date of Event
    January 30, 2019
    Report Date
    January 30, 2019
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    HJH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE WAS ONE LED LOUPES LIGHT UNIT RETURNED SHOWING WEAR. THIS UNIT WAS RETURNED FOR THE REASON THE CHARGER IS GETTING HOT. TESTED THE BATTERY WITH THE CHARGER OVER NIGHT, THE CHARGER WAS WARM BUT NOT HOT. THERE WAS ANOTHER COMPLAINT THAT THE BATTERY DOES NOT FIT INTO THE BATTERY PACK, THIS IS CONFIRMED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE PINS BEING SLIGHTLY BENT. THIS COMPLAINT IS CONFIRMED/DAMAGED WORN. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. DEVICE IDENTIFIER (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON (B)(6) 2019, THE BATTERY PACK AND CHARGER OF 15050 LED LOUPES LIGHT UNIT WAS HOT. THE PRODUCT WAS NOT IN CONTACT WITH THE PATIENT. NO PATIENT INJURY OR DEATH ALLEGED, AND THE EVENT DID NOT LEAD TO INCREASE THE SURGERY TIME. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019 BY THE HOSPITAL MANAGER STATED THAT THE CHARGER THEY RECEIVED WAS NOT THE ONE PICTURED ON THE FRONT OF THE MANUAL, WHICH WAS THE ONE THEY BORROWED WHEN TESTING OUT THE LOUPES. THE CHARGER AND BATTERY DID NOT FIT WELL TOGETHER. THE CHARGER GOT HOT AS THE BATTERY WAS CHARGING, BUT PROBABLY FEELS THIS IS DUE TO THE TWO (2) PIECES NOT FITTING WELL TOGETHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162163 LED LOUPES LIGHT UNIT M5 - GENERAL SURGERY HJH INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1