BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNIA

    MDR report key: 16841331 · Received April 30, 2023

    Report

    Report Number
    2217809-2022-00002
    Event Type
    Malfunction
    Date Received
    April 30, 2023
    Date of Event
    May 3, 2022
    Report Date
    April 29, 2023
    Manufacturer
    SIVANTOS, INC.
    Product Code
    OSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PLASTIC OF THE CHARGER MELTED AROUND THE USB SOCKET.. NO BURN MARKS. NO INJURY AND NO MEDICAL INTERVENTION REQUIRED. HEARING CARE PROFESSIONAL INDICATED THE PATIENT TAKES RESPONSIBILITY AS SHE HAD A PILE OF CLOTHES SITTING ON TOP OF THE CHARGER AND THOUGHT IT OVERHEATED. INVESTIGATION FOUND THAT THE HEAT SOURCE ORIGINATED FROM THE CABLE (THE DESIGN OF 24 PINS FOR THE TYPE C USB CABLE WAS FOUND TO HAVE INSUFFICIENT SOLDER, THE PIN DEFORMED AND SHORT ON THE PIN. AS A CORRECTIVE ACTION WE HAVE CHANGED THE DESIGN OF TYPE C USB CABLE: 24 PINS ON THE TYPE C CONNECTOR REDUCE TO 12PIN TO LOWER THE RISK OF INSUFFICIENT SOLDER, PIN DEFORM AND SHORT. ADD PTC (PN:LP-NSM075F) WHICH ENABLES PROTECTION WHEN THE CURRENT IS OVERLOADED . ECR ALREADY APPROVED BY WSA AND NEW DESIGN CABLES ALREADY SHIPPED TO WSA FROM 25TH JUNE 2022. THERE IS AN OVERALL CAPA ADDRESSING AND CORRECTING THE ISSUE WITH THE USB CABLE.

    Description of Event or Problem · 0

    THE PLASTIC OF THE CHARGER MELTED AROUND THE USB SOCKET. NO BURN MARKS. NO INJURY AND NO MEDICAL INTERVENTION REQUIRED. HEARING CARE PROFESSIONAL INDICATED THE PATIENT TAKES FULL RESPONSIBILITY AS SHE HAD A PILE OF CLOTHES SITTING ON TOP OF THE CHARGER SO IT PROBABLY OVERHEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349925 SIGNIA SIGNIA PORTABLE CHARGER RIC FOR HEARING AID OSM SIVANTOS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female