BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    MDR report key: 2230328 · Received September 1, 2011

    Report

    Report Number
    1031452-2011-00005
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 4, 2011
    Report Date
    November 11, 2011
    Manufacturer
    INVACARE FLORIDA OPERATIONS
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN ISSUED FOR THE RETURN OF THIS BED. THE CONSUMER WAS UNABLE TO GET OUT OF THE BED DUE TO THE BENT RAILS. THIS IS INCONSISTENT WITH THE ENTRAPMENT WITHIN 7 AREAS AS CLASSIFIED BY THE FDA WEBSITE. THE BED IS APPROXIMATELY 5 YEARS OLD. THE MAINTENANCE HISTORY OF THE BED IS UNKNOWN. IT IS UNKNOWN IF THE CONSUMER FULLY READ AND UNDERSTANDS THE USER MANUAL PN 1114836 REV D. PAGE 2 OF THE MANUAL PROVIDES THIS WARNING: "DO NOT USE THIS PRODUCT OR ANY AVAILABLE OPTIONAL EQUIPMENT WITHOUT FIRST COMPLETELY READING AND UNDERSTANDING THESE INSTRUCTIONS AND ANY ADDITIONAL INSTRUCTIONAL MATERIAL SUCH AS OWNER'S MANUALS, SERVICE MANUALS OR INSTRUCTION SHEETS SUPPLIED WITH THIS PRODUCT OR OPTIONAL EQUIPMENT. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS OR INSTRUCTIONS, CONTACT A HEALTHCARE PROFESSIONAL, DEALER OR TECHNICAL PERSONNEL BEFORE ATTEMPTING TO USE THIS EQUIPMENT - OTHERWISE, INJURY OR DAMAGE MAY OCCUR. THE INITIAL SET UP OF THIS BED MUST BE PERFORMED BY A QUALIFIED TECHNICIAN. PROCEDURES OTHER THAN THOSE DESCRIBED IN THIS MANUAL MUST BE PERFORMED BY A QUALIFIED TECHNICIAN. FOR DEALERS ONLY - SET-UP AND ASSEMBLY INSTRUCTIONS ARE IN THE REAR OF THIS MANUAL. THESE PROCEDURES MUST BE PERFORMED BY A QUALIFIED TECHNICIANS ONLY." ON PAGE 32 INVACARE RECOMMENDS MAINTENANCE CHECKS OF THE FOLLOWING ITEMS EVERY 3 YEARS. IT IS UNKNOWN IF THE CONSUMER HAS HAD THE FOLLOWED THE ITEMS CHECKED ON THIS LIST PRIOR TO THIS ISSUE. "INSPECT THE BED FOR DAMAGE OR EXCESSIVE WEAR; VISIBLY CHECK ALL WELDS FOR CRACKS; INSPECT THE HEAD AND FOOT SECTIONS FOR BENDING, WARPING OR DAMAGE; CHECK DRIVE SHAFT AND DRIVE SHAFT CONNECTIONS FOR BENDING, DAMAGE OR EXCESSIVE WEAR; INSPECT ALL TUBES AND MOUNTING HARDWARE FOR BENDING, DAMAGE OR EXCESSIVE WEAR; INSPECT ALL BOLTS AND RIVETS TO ENSURE THEY ARE SECURELY TIGHTENED AND FUNCTIONING PROPERLY. CHECK SLEEPING SURFACES TO ENSURE ALL LINKS ARE SECURE. CHECK CASTERS TO MAKE SURE THEY LOCK, IF APPLICABLE, AND ROLL PROPERLY. " (B)(4) - NO WELD BREAK COULD BE FOUND. THE BED WAS BUILT PER REQUIREMENT AND THE RAILS WERE NOT BENT. BY DESIGN, THE BED MET SPECIFICATIONS. OPERATOR ERROR DURING SET-UP IS SUSPECTED.

    Additional Manufacturer Narrative · 1

    NO RMA HAS BEEN ISSUED FOR THE RETURN OF THIS BED. THE CONSUMER WAS UNABLE TO GET OUT OF THE BED DUE TO THE BENT RAILS. (B)(4). THE BED IS APPROXIMATELY 5 YEARS OLD. THE MAINTENANCE HISTORY OF THE BED IS UNKNOWN. IT IS UNKNOWN IF THE CONSUMER FULLY READ AND UNSDERSTANDS THE USER MANUAL PN 1114836 REV D. PAGE 2 OF THE MANUAL PROVIDES THIS WARNING: "DO NOT USE THIS PRODUCT OR ANY AVAILABLE OPTIONAL EQUIPMENT WITHOUT FIRST COMPLETELY READING AND UNDERSTANDING THESE INSTRUCTIONS AND ANY ADDITIONAL INSTRUCTIONAL MATERIAL SUCH AS OWNER'S MANUALS, SERVICE MANUALS OR INSTRUCTION SHEETS SUPPLIED WITH THIS PRODUCT OR OPTIONAL EQUIPMENT. IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS, CAUTIONS OR INSTRUCTIONS, CONTACT A HEALTHCARE PROFESSIONAL, DEALER OR TECHNICAL PERSONNEL BEFORE ATTEMPTING TO USE THIS EQUIPMENT OTHERWISE, INJURY OR DAMAGE MAY OCCUR. THE INITIAL SET UP OF THIS BED MUST BE PERFORMED BY A QUALIFIED TECHNICIAN. PROCEDURES OTHER THAN THOSE DESCRIBED IN THIS MANUAL MUST BE PERFORMED BY A QUALIFIED TECHNICIAN. FOR DEALERS ONLY - SET-UP AND ASSEMBLY INSTRUCTIONS ARE IN THE REAR OF THIS MANUAL. THESE PROCEDURES MUST BE PERFORMED BY A QUALIFIED TECHNICIANS ONLY." ON PAGE 32 INVACARE RECOMMENDS MAINTENANCE CHECKS OF THE FOLLOWING ITEMS EVERY 3 YEARS. IT IS UNKNOWN IF THE CONSUMER HAS HAD THE FOLLOWED THE ITEMS CHECKED ON THIS LIST PRIOR TO THIS ISSUE. "INSPECT THE BED FOR DAMAGE OR EXCESSIVE WEAR, VISIBLY CHECK ALL WELDS FOR CRACKS, INSPECT THE HEAD AND FOOT SECTIONS FOR BENDING, WARPING OR DAMAGE, CHECK DRIVE SHAFT AND DRIVE SHAFT CONNECTIONS FOR BENDING, DAMAGE OR EXCESSIVE WEAR, INSPECT ALL TUBES AND MOUNTING HARDWARE FOR BENDING, DAMAGE OR EXCESSIVE WEAR, INSPECT ALL BOLTS AND RIVETS TO ENSURE THEY ARE SECURELY TIGHTENED AND FUNCTIONING PROPERLY. CHECK SLEEPING SURFACES TO ENSURE ALL LINKS ARE SECURE. CHECK CASTERS TO MAKE SURE THEY LOCK, IF APPLICABLE, AND ROLL PROPERLY. "

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE LIFT ARM WELD ON THE BED IS BROKEN AND THE HEAD MOTOR CONTINUES TO RUN IN THE UP POSITION. THE BED RAILS ARE ALLEGEDLY BENT AS A RESULT, PREVENTING THE CONSUMER FROM GETTING OUT OF THE BED. NO INJURY IS ALLEGED.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES THE LIFT ARM WELD ON THE BED IS BROKEN AND THE HEAD MOTOR CONTINUES TO RUN IN THE UP POSITION. THE BED RAILS ARE ALLEGEDLY BENT AS A RESULT, PREVENTING THE CONSUMER FROM GETTING OUT OF THE BED. NO 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 5310IVC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 DA Other