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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HILL-ROM BATESVILLE PROGRESSA FRAME; BED FLOTATION THERAPY POWERED
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HILL-ROM BATESVILLE PROGRESSA FRAME; BED FLOTATION THERAPY POWERED Back to Search Results
Model Number P7500A001643
Device Problems Use of Device Problem (1670); Pressure Problem (3012)
Patient Problems Erythema (1840); Pressure Sores (2326)
Event Date 05/18/2021
Event Type  Injury  
Manufacturer Narrative
The customer has been asked to provide further details on the patient, an intervention or treatment provided to the patient impacted by this event or the state of the bed and surface in use.The development of pressure injuries is multifactorial and cannot only be attributed to the performance of 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.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.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.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.A stage 1 pressure injury is intact skin that may be painful, appears reddened, and does not blanch.A stage 2 pressure injury is characterized by partial-thickness skin loss no deeper than the dermis and can include intact or ruptured blisters.Stage 1 and 2 pressure injuries can heal very rapidly therefore treatment is focused on nutrition to support wound healing and keeping the area protected/covered and clean.However, a stage 3 pressure injury involves full thickness of the skin and may extend into the subcutaneous tissue layer, granulation tissue and tunneling may also be present.Treatment for a stage 3 pressure injury may involve medical or surgical intervention to preclude permanent impairment of the body structure.Therefore this event is a reportable serious injury.
 
Event Description
The customer contributes the patient's stage 3 sacral pressure injury, stage 2 bilateral heels pressure injuries, and stage 1 pressure injury on the back to the use of the progressa bed.Details of the medical intervention provided, the patient¿s past medical history, or positioning protocols were not provided.This report was filed in our complaint handling system as complaint # (b)(4).
 
Event Description
The customer contributes the patient's stage 3 sacral pressure injury, stage 2 bilateral heels pressure injuries, and stage 1 pressure injury on the back to the use of the progressa bed.Details of the medical intervention provided, the patient¿s past medical history, or positioning protocols were not provided.This report was filed in our complaint handling system as complaint # (b)(4).
 
Manufacturer Narrative
The customer contributes the patient's stage 3 sacral pressure injury, stage 2 bilateral heels pressure injuries, and stage 1 pressure injury on the back to the use of the progressa bed.Details of the medical intervention provided, the patient¿s past medical history, or positioning protocols were not provided despite multiple attempts.As the customer cannot specify which patient was on which bed all 6 beds and surfaces were thoroughly inspected by the hrc technician and it was confirmed that the beds are functioning correctly, there was no evidence of a malfunction.Hill-rom was unable to duplicate the alleged condition.The technician performed a functional, visual, and audible test per the service manual and the bed functioned as designed.Airflow works with 30kg on the bed.All values are within the ranges of the technical documentation.The pressures measured were in compliance with the expectations.No malfunction, the bed was performing within specifications.The progressa® bed is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.The progressa® bed is intended to provide a patient support to be used in health care environments.The progressa® bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (pacu), and sections of the emergency department (ed).The progressa® bed is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.The progressa integrated air mattress is a therapy surface option for the progressa bed system.The development of pressure injuries is multifactorial and cannot only be attributed to the performance of 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.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.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.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.No malfunction was identified during inspection of the bed and determined to function as designed.A stage 1 pressure injury is intact skin that may be painful, appears reddened, and does not blanch.A stage 2 pressure injury is characterized by partial-thickness skin loss no deeper than the dermis and can include intact or ruptured blisters.Stage 1 and 2 pressure injuries can heal very rapidly therefore treatment is focused on nutrition to support wound healing and keeping the area protected/covered and clean.A stage 1 and 2 pressure injury do not meet the definition of a serious injury.However, a stage 3 pressure injury involves full thickness of the skin and may extend into the subcutaneous tissue layer, granulation tissue and tunneling may also be present.Treatment for a stage 3 pressure injury may involve medical or surgical intervention to preclude permanent impairment of the body structure.Therefore this event , a stage 3 pressure injury, is a reportable serious injury.Based on this information, no further action is required.
 
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Brand Name
PROGRESSA FRAME
Type of Device
BED FLOTATION THERAPY POWERED
Manufacturer (Section D)
HILL-ROM BATESVILLE
1069 state route 46 east
batesville IN 47006
MDR Report Key11991339
MDR Text Key255937532
Report Number1824206-2021-00305
Device Sequence Number1
Product Code IOQ
UDI-Device Identifier00887761000100
UDI-Public010088776100010011210331
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberP7500A001643
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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