BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIA-CHAIR

    MDR report key: 925583 · Received September 7, 2007

    Report

    Report Number
    925583
    Event Type
    Injury
    Date Received
    September 7, 2007
    Date of Event
    August 11, 2007
    Report Date
    September 7, 2007
    Manufacturer
    DISCOUNT MEDICAL SUPPLY
    Product Code
    FKS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT TURNED ON THE HEATING COMPONENT OF THE CHAIR AND FELL ASLEEP WITH THE BACK OF HER NECK PRESSED AGAINST THE BACK OF THE CHAIR. PATIENT REPORTS NOT FEELING ANY EXCESSIVE HEAT DURING OR AFTER THE TREATMENT BUT DID DISCOVER TWO SMALL BLISTERS ON HER NECK THE FOLLOWING DAY AND REPORTED IT TO THE UNIT WHEN SHE RETURNED THREE DAYS LATER. A PHYSICIAN WAS PRESENT TO EXAMINE THE PATIENT ON THE DATE OF HER RETURN AND WITNESSED THE BLISTERS. BAND AIDS WERE APPLIED AND NO FURTHER TREATMENT WAS REQUIRED. ALL CHAIRS WERE DISCONNECTED FORM THE ELECTRICAL OUTLETS UNTIL THE MANUFACTURER ARRIVES TO ADJUST THE HEAT SETTING AND AUTOMATIC SHUT OFF CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIA-CHAIR DIALYSIS CHAIR FKS DISCOUNT MEDICAL SUPPLY 5800-37HM *

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention DIALYSIS