BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLINQ PEDIATRIC VISION SCANNER

    MDR report key: 18461117 · Received January 6, 2024

    Report

    Report Number
    3014522421-2022-00002
    Event Type
    Malfunction
    Date Received
    January 6, 2024
    Date of Event
    February 12, 2022
    Report Date
    February 12, 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
    NZ
    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 THE DEVICE POWERS ON, BUT THE TOUCHSCREEN DOES NOT LIGHT UP. THE CUSTOMER IS UNABLE TO OPERATE THE DEVICE IN ITS CURRENT STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600576 BLINQ PEDIATRIC VISION SCANNER STRABISMUS DETECTION DEVICE PMW REBISCAN, INC. BQ830

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown