BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BED EXTENDER 9153650579

    MDR report key: 5608962 · Received April 26, 2016

    Report

    Report Number
    1031452-2016-01969
    Event Type
    Malfunction
    Date Received
    April 26, 2016
    Report Date
    June 14, 2016
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED. REFERENCE REPORT NUMBER 1031452-2016-01663 FOR SERIOUS INJURY PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4) CREATED FOR THIS EVENT. (B)(4) CREATED TO RESOLVE ISSUE. NO IMMEDIATE RISK NOTED WITH EVENT TO ESCALATE TO CAPA/CRT. ONE SERIOUS INJURY NOTED OUT OF ALL 172 BED THROUGHOUT A SINGLE BUSINESS UNIT. COMPLAINT DATA OVER A 2 YEAR PERIOD DID NOT SHOW ANY SIMILAR ISSUES OR INJURIES WITH THE IHSC900DLX BED. CONCLUSIONS OF ERB SHOW THAT THE UNDERLYING CAUSE APPEARS TO BE METAL BURS LEFT AFTER MOLDING. REFERENCE REPORT NUMBER 1031452-2016-01663 FOR SERIOUS INJURY PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THE REPLACEMENT BED, THEY RECEIVED HAD ARRIVED WITH SHARP LIKE EDGES.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THE REPLACEMENT BED THEY RECEIVED HAD ARRIVED WITH SHARP LIKE EDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265731 BED EXTENDER 9153650579 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL INVACARE FLORIDA OPERATIONS SC900-80WDLX-QSP

    Patients

    Seq Age Sex Outcome Treatment
    1