BEUDAMED
    FDA Adverse Event Other Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2100385 · Received May 16, 2011

    Report

    Report Number
    1525712-2011-00198
    Event Type
    Other
    Date Received
    May 16, 2011
    Date of Event
    April 9, 2011
    Report Date
    August 16, 2011
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER ALLEGEDLY HEARD SOMETHING SNAP AND THEN BLACKED OUT. NO SERIAL NUMBER OR MAINTENANCE HISTORY IS AVAILABLE AT THIS TIME. IT IS UNK IF THE COMPLAINT IS A RESULT OF LACK OF MAINTENANCE, MECHANICAL WEAR OR A MALFUNCTION. THERE IS NO HISTORY TO SUGGEST A PRODUCT PROBLEM. MDR FILED AS A CONSERVATIVE MEASURE BASED ON ALLEGED INJURY TO THEIR BACK AND PRESCRIBED PAIN MEDICINE. MFR IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.

    Additional Manufacturer Narrative · 1

    THE USER ALLEGEDLY HEARD SOMETHING SNAP AND THEN BLACKED OUT . NO SERIAL NUMBER OR MAINTENANCE HISTORY IS AVAILABLE AT THIS TIME. IT IS UNKNOWN IF THE COMPLAINT IS A RESULT OF LACK OF MAINTENANCE, MECHANICAL WEAR OR A MALFUNCTION. THERE IS NO HISTORY TO SUGGEST A PRODUCT PROBLEM. MDR FILED AS A CONSERVATIVE MEASURE BASED ON ALLEGED INJURY TO THEIR BACK AND PRESCRIBED PAIN MEDICINE. MANUFACTURER IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.(B)(4).

    Additional Manufacturer Narrative · 1

    THE USER ALLEGEDLY HEARD SOMETHING SNAP AND THEN BLACKED OUT . NO SERIAL NUMBER OR MAINTENANCE HISTORY IS AVAILABLE AT THIS TIME. IT IS UNKNOWN IF THE COMPLAINT IS A RESULT OF LACK OF MAINTENANCE, MECHANICAL WEAR OR A MALFUNCTION. THERE IS NO HISTORY TO SUGGEST A PRODUCT PROBLEM. MDR FILED AS A CONSERVATIVE MEASURE BASED ON ALLEGED INJURY TO THEIR BACK AND PRESCRIBED PAIN MEDICINE. MANUFACTURER IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.(B)(4)

    Description of Event or Problem · 1

    THE CONSUMER WAS EATING DINNER WHEN HE ALLEGEDLY HEARD SOMETHING SNAP. HE ALLEGEDLY BLACKED OUT AND WHEN HE AWOKE, THE PARAMEDICS WERE THERE. HE ALLEGEDLY HAD A CAT SCAN AND WAS RELEASED THE SAME DAY. THE CONSUMER HAD BACK SURGERY 3 DAYS BEFORE THE ALLEGED INCIDENT OCCURRED. NO SERIOUS INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER WAS EATING DINNER WHEN HE ALLEGEDLY HEARD SOMETHING SNAP. HE ALLEGEDLY BLACKED OUT AND WHEN HE AWOKE, THE PARAMEDICS WERE THERE. HE ALLEGEDLY HAD A CAT SCAN AND WAS RELEASED THE SAME DAY. THE CONSUMER HAD BACK SURGERY 3 DAYS BEFORE THE ALLEGED INCIDENT OCCURRED. NO SERIOUS INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER WAS EATING DINNER WHEN HE ALLEGEDLY HEARD SOMETHING SNAP. HE ALLEGEDLY BLACKED OUT AND WHEN HE AWOKE, THE PARAMEDICS WERE THERE. HE ALLEGEDLY HAD A CAT SCAN AND WAS RELEASED THE SAME DAY. THE CONSUMER HAD BACK SURGERY 3 DAYS BEFORE THE ALLEGED INCIDENT OCCURRED. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS 880.5100 FNL INVACARE FLORIDA OPERATIONS 5410IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other