BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9RC 9000 XT RECLINER 9153638254

    MDR report key: 5331523 · Received December 29, 2015

    Report

    Report Number
    9616091-2015-02973
    Event Type
    Malfunction
    Date Received
    December 29, 2015
    Report Date
    January 12, 2016
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL/UPDATED INFORMATION WAS ADDED TO REFLECT THE DEVICE RECEIVING AN EXPANDED EVALUATION, WHICH FURTHER IDENTIFIED THAT FOUR OF THE SIX PINS CONNECTING THE LEFT HAND RIM TO THE WHEEL WERE BENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION, AND SUBSEQUENT TESTING VERIFIED THE COMPLAINT OF A BENT WHEEL; HOWEVER, IT WAS IDENTIFIED THAT IT WAS THE LEFT WHEEL (AND HAND RIM), NOT THE RIGHT. THE UNDERLYING CAUSE WAS IDENTIFIED AS FREIGHT DAMAGE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER SAID THIS CHAIR ARRIVED WITH SOME DAMAGE. THE RIGHT REAR WHEEL IS BENT, THE HAND RIM TOO. SHE IS THINKING THEY PROBABLY JUST NEED A WHOLE NEW CHAIR BECAUSE THEY THINK THAT THE INTEGRITY OF THE CHAIR HAS BEEN COMPROMISED. THE PRODUCT WAS RETURNED FOR EVALUATION, AND SUBSEQUENT TESTING VERIFIED THE COMPLAINT OF A BENT WHEEL; HOWEVER, IT WAS IDENTIFIED THAT IT WAS THE LEFT WHEEL (AND HAND RIM), NOT THE RIGHT. AN EXPANDED EVALUATION WAS PERFORMED AND FURTHER IDENTIFIED THAT FOUR OF THE SIX PINS CONNECTING THE LEFT HAND RIM TO THE WHEEL WERE BENT.

    Description of Event or Problem · 1

    THE CUSTOMER SAID THIS CHAIR ARRIVED WITH SOME DAMAGE. THE RIGHT REAR WHEEL IS BENT, THE HAND RIM TOO. SHE IS THINKING THEY PROBABLY JUST NEED A WHOLE NEW CHAIR BECAUSE THEY THINK THAT THE INTEGRITY OF THE CHAIR HAS BEEN COMPROMISED. THE PRODUCT WAS RETURNED FOR EVALUATION, AND SUBSEQUENT TESTING VERIFIED THE COMPLAINT OF A BENT WHEEL; HOWEVER, IT WAS IDENTIFIED THAT IT WAS THE LEFT WHEEL (AND HAND RIM), NOT THE RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855098 9RC 9000 XT RECLINER 9153638254 WHEELCHAIR, MECHANICAL IOR INVAMEX 9TPZ

    Patients

    Seq Age Sex Outcome Treatment
    1