BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSACARE FRAME

    MDR report key: 7560017 · Received June 1, 2018

    Report

    Report Number
    1824206-2018-00211
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    April 11, 2018
    Report Date
    May 11, 2018
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE HILL-ROM TECHNICIAN FOUND THE MICRO-CLIMATE BLOWER NEEDED TO BE REPLACED. THE TECHNICIAN PUT IN AN ORDER WITH TECHNICAL SUPPORT TO COMPLETE THE REPAIR. THE PATIENT WAS BEING TREATED WITH SILVADENE CREAM. THE PATIENT HAS BEEN ADMITTED TO THE HOSPITAL AND THE DOCTOR WILL ADVISE WHETHER OR NOT SURGERY IS NECESSARY. A STAGE 4 PU IS FULL THICKNESS TISSUE LOSS WITH EXPOSED BONE, TENDON OR MUSCLE AND THEREFORE MEETS THE FDA DEFINITION OF SERIOUS INJURY AND THE (B)(4) DEFINITION FOR SERIOUS DETERIORATION IN STATE OF HEALTH AS IT NECESSITATES MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE PATIENT HAD DEVELOPED A WOUND ON HIS LEFT SIDE BUTTOCK AND IT QUICKLY PROGRESSED TO A STAGE 4. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS A PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403532 VERSACARE FRAME A/C POWERED ADJUSTABLE HOSPITAL BED FNL HILL-ROM BATESVILLE P3200K000368

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR