BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGRESSA FRAME

    MDR report key: 13573194 · Received February 21, 2022

    Report

    Report Number
    1824206-2022-00068
    Event Type
    Injury
    Date Received
    February 21, 2022
    Date of Event
    December 25, 2021
    Report Date
    February 21, 2022
    Manufacturer
    HILL-ROM BATESVILLE
    Product Code
    FNL
    UDI-DI
    00887761000100
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED AN INCREASE IN PRESSURE INJURIES AMONG PATIENTS WITH THE USE OF THE HILLROM PROGRESSA BED IN THE FACILITY¿S CIT INTENSIVE CARE UNIT. THE INJURIES WERE REPORTED TO BE STAGE 3 / STAGE 4 PRESSURE INJURIES HOWEVER, SPECIFIC DETAILS OF THE EVENT INCLUDING, CLARIFICATION IF THE ASSOCIATED PATIENT¿S PRESSURE INJURIES WERE PREEXISTING, THE MEDICAL TREATMENT PROVIDED FOR THE INJURY, PATIENT¿S MEDICAL HISTORY, ACCESSORY DEVICES UTILIZED, AND FACILITIES POSITIONING PROTOCOLS WERE NOT PROVIDED. ADDITIONALLY, THE CUSTOMER DID NOT ASSOCIATE A PATIENT WITH A SPECIFIC SERIAL BED/SERIAL NUMBER. FOLLOW-UP WITH THE CUSTOMER FOUND THAT 13 PATIENTS DEVELOPED PRESSURE INJURIES CONTRIBUTED TO THE USE OF THE BED. EACH PATIENT WILL BE EVALUATED INDIVIDUALLY. THIS REPORT IS IN REFERENCE TO PATIENT 12 FOR PROGRESSA BED WITH SERIAL # (B)(4). THIS PATIENT IS AN (B)(6)-YEAR OLD MALE WITH A MEDICAL HISTORY OF SERIOUS HEAD INJURY, KAF, AH, HLP, STOOL INCONTINENCE, AND SUK INSERTED. IT IS NOTED THAT THE PATIENT WAS ¿NOT BEING TURNED FOR AT LEAST THE FIRST FEW DAYS.¿ THIS PATIENT WAS REPORTED TO HAVE SUSPECTED DEEP TISSUE INJURY ON THE LEFT GLUTEUS. MEDICAL INTERVENTION FOR PRESSURE INJURY INCLUDED SILICONE POLYURETHANE FOAM/FILM. THE PROGRESSA BED IS INTENDED TO BE USED TO TREAT OR PREVENT PULMONARY OR OTHER COMPLICATIONS ASSOCIATED WITH IMMOBILITY, PRESSURE ULCERS, OR FOR ANY OTHER USE WHERE MEDICAL BENEFITS MAY BE DERIVED FROM EITHER CONTINUOUS LATERAL ROTATION THERAPY OR PERCUSSION/VIBRATION THERAPY. THE INSTRUCTIONS FOR USE (IFU) STATES THE THERAPY SURFACE IS NOT A SUBSTITUTE FOR GOOD NURSING PRACTICE. THE DEVELOPMENT OF PRESSURE INJURIES IS MULTIFACTORIAL AND CANNOT ONLY BE ATTRIBUTED TO THE PERFORMANCE OF THE SURFACE OR THE PROGRESSA BED. PRESSURE INJURIES CAN DEVELOP WITHIN 2-6 HOURS WHEN CAPILLARIES SUPPLYING THE SKIN AND SUBCUTANEOUS TISSUES ARE COMPRESSED, CAUSING AN OBSTRUCTION IN BLOOD FLOW, WHICH ULTIMATELY LEADS TO TISSUE NECROSIS. POSITION CHANGES ARE KEY TO PRESSURE INJURY PREVENTION AND TREATMENT. THESE CHANGES NEED TO BE FREQUENT, REPOSITIONING NEEDS TO AVOID STRESS ON THE SKIN, AND BODY POSITIONS NEED TO MINIMIZE THE RISK OF PRESSURE ON VULNERABLE AREAS. PREVENTION OF PRESSURE INJURIES INVOLVES A MULTIDISCIPLINARY APPROACH INCLUDING RAPID IDENTIFICATION OF AT-RISK INDIVIDUALS SUCH AS THOSE WITH DIABETES, INCONTINENCE, IMPAIRED MOBILITY, PERIPHERAL VASCULAR DISEASE, ETC., AND EXERCISING A VIGILANT PREVENTION PROTOCOL CONSISTING OF SKINCARE, NUTRITIONAL ASSESSMENT REDUCING MECHANICAL LOAD, AND UTILIZING SUPPORT SURFACES. IT IS NOTED THAT AN INSPECTION OF THE ASSOCIATED BEDS WAS PERFORMED BY THE MEDICOENGINEERING TEAM AND WAS FOUND TO BE IN PERFECT TECHNICAL WORKING ORDER. INVESTIGATION INDICATED THAT THERE WAS NO EVIDENCE OF A MALFUNCTION. THE TECHNICIAN PERFORMED A FUNCTIONAL, VISUAL, AND AUDIBLE TEST PER THE SERVICE MANUAL AND THE BED FUNCTIONED AS DESIGNED WITH NO ERROR CODES. A SEARCH OF THE HILLROM MAINTENANCE RECORDS DID NOT SHOW HILLROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. AS NOTED ABOVE, PRESSURE INJURIES CAN DEVELOP WITHIN 2-6 HOURS, WHEN CAPILLARIES SUPPLYING THE SKIN AND SUBCUTANEOUS TISSUES ARE COMPRESSED, CAUSING AN OBSTRUCTION IN BLOOD FLOW, WHICH ULTIMATELY LEADS TO TISSUE NECROSIS. PREVENTION OF PRESSURE INJURIES INVOLVES A DISCIPLINED APPROACH INCLUDING IDENTIFYING AT-RISK INDIVIDUALS, REPOSITIONING, ETC.. ADDITIONALLY, THE DEVICE INSTRUCTIONS FOR USE (IFU) STATES THE THERAPY SURFACE IS NOT A SUBSTITUTE FOR GOOD NURSING PRACTICE. BASED ON THE REPORT THAT THE BED WAS FOUND TO BE FUNCTIONING AS DESIGNED IT IS UNLIKELY THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INJURY CAN BE CONTRIBUTED TO THE FAILURE TO REPOSITION THE PATIENT AS REPORTED BY THE CUSTOMER THAT THE PATIENT WAS 'NOT POSITIONED FOR THE FIRST FEW DAYS.' A DEEP TISSUE PRESSURE INJURY OFTEN REQUIRES MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT AND THEREFORE MEETS THE DEFINITION OF A REPORTABLE SERIOUS INJURY. THIS COMPLAINT REMAINS A REPORTABLE SERIOUS INJURY FOR REASONS STATED ABOVE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED AN INCREASE IN PRESSURE INJURIES AMONG PATIENTS WITH THE USE OF THE HILLROM PROGRESSA BED IN THE FACILITY¿S CIT INTENSIVE CARE UNIT. THE INJURIES WERE REPORTED TO BE STAGE 3 / STAGE 4 PRESSURE INJURIES. THE BED WAS LOCATED AT THE ACCOUNT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224715 PROGRESSA FRAME BED, AC-POWERED ADJUSTABLE HOSPITAL FNL HILL-ROM BATESVILLE P7500A001648 00887761000100

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Other