BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLINQ PEDIATRIC VISION SCANNER

    MDR report key: 18433807 · Received January 3, 2024

    Report

    Report Number
    3014522421-2022-00009
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    October 18, 2022
    Report Date
    October 18, 2022
    Manufacturer
    REBISCAN, INC.
    Product Code
    PMW
    PMA / PMN Number
    DEN130051
    Removal / Correction Number
    3014522421-10/03/22-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INABILITY OF THE DEVICE TO CHARGE HAS BEEN ATTRIBUTED TO THE BATTERY PACK. THE BATTERY PACK IS AN OFF-THE-SHELF BATTERY PACK THAT IS DESIGNED BY THE BATTERY-PACK SUPPLIER TO HAVE UNDER-VOLTAGE PROTECTION, WHICH WOULD PREVENT A BATTERY PACK HAVING LESS THAN 2.5V/CELL FROM BEING CHARGED. THE SUPPLIER OF THE BATTERY PACK HAD DISABLED THIS FEATURE WITHOUT NOTIFYING CUSTOMERS. THE RESULT MAY LEAD TO A BATTERY PACK TO VENT, WHICH COULD LEAD TO A FIRE, IF THE BATTERY PACK WITH LESS THAN 2.5V/CELL IS ATTEMPTED TO BE CHARGED. A REMOVAL UNDER 21 CFR PART 810 HAS BEEN INITIATED. AN APPROPRIATE CONCLUSION CODE IS NOT AVAILABLE. CAUSE IS ATTRIBUTED TO SUPPLIER ERROR FOR OFF-THE-SHELF COMPONENT. REF: MFR FILE (B)(4). THIS REPORT IS SUBMITTED LATE. THIS IS THE COMPANY'S FIRST ELECTRONIC MDR SUBMISSION AND IS LATE DUE TO DELAYS AND ISSUES ENCOUNTERED DURING THE SIGN-UP PROCESS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DEVICE WILL NOT CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550399 BLINQ PEDIATRIC VISION SCANNER STRABISMUS DETECTION DEVICE PMW REBISCAN, INC. BQ830

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown