BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED MOV CHAIR

    MDR report key: 1507401 · Received October 2, 2009

    Report

    Report Number
    1831750-2009-01351
    Event Type
    Malfunction
    Date Received
    October 2, 2009
    Date of Event
    September 3, 2009
    Report Date
    September 3, 2009
    Manufacturer
    PARAMED
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT THE BATTERY METER ILLUSTRATED TWO BARS. THE OPERATIONS MANUAL STATED THAT A TWO BAR READING INDICATES THAT THE BATTERY NEEDS TO BE CHARGED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PARAPLEGIC CUSTOMER WAS STUCK ON THE UPPER LEVEL OF HIS HOME WHEN THE BATTERY ON HIS MOV CHAIR CEASED TO FUNCTION. NO ADVERSE CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED MOV CHAIR POWERED PATIENT TRANSPORT ITI PARAMED 12-000-00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK