MAUDE Adverse Event Report: HILL-ROM BATESVILLE PROGRESSA FRAME; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P7500A001494

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/30/2023

Event Type  malfunction  

Event Description

The customer reported a hospitalized patient developed a potential deep tissue injury (pdti) with use of the progressa bed and mattress.There was no allegation of a device malfunction reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The customer reported a hospitalized patient developed a potential deep tissue injury (pdti) with use of the progressa bed and mattress.There was no allegation of a device malfunction reported.The patient in this event is a 42-year-old female.Admitting diagnosis and medical history was not provided.A purpose t pressure ulcer risk assessment was performed upon admission and the score was ¿amber¿ and no pressure damage noted.On (b)(6) 2023, the patient developed a pdti to the natal cleft.The hospital¿s turning protocol was increased from every 4 hours to every 2 hours.The tissue viability nurse (tvn) was consulted; however, the outcome of the assessment was not provided, and no medical treatment was reported.Hospital supplied bed linen was used with no report of additional materials being used under the patient.Although no malfunction of the bed was reported, the customer alleged the progressa bed contributed to the development of the pdti.Attempts to obtain additional information from the customer were unsuccessful.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.A deep tissue pressure injury (dti) is a persistent non-blanchable deep red, purple or maroon area of intact skin, non-intact skin or blood-filled blisters caused by damage to the underlying soft tissues from pressure and/or shear¿.Dti occurs in the tissue that has been subjected to pressures that exceed the tolerance level of muscle tissue.The diagnosis of dti should begin with a history of the patient's exposure to intense pressure, which leads to direct muscle damage.The specific risk profile for dti is seen during periods of ¿confinement¿ on a hard surface such as the floor following falls, ¿found down¿ events, long stays in interventional radiology or magnetic resonance imaging and even on relatively hard surfaces such as the operating room table.During events on hard surfaces, the pressure is intense enough to lead to the deformation of muscle cells leading to dtis in short periods.The potential dtis reported by the customer in this case are localised in areas (natal cleft and skin folds) that are not commonly subjected to direct pressure from the underlying bones and would unlikely be in direct contact with hard surfaces for an extended period of time.Additionally, the customer confirmed there were not any additional device(s) being used in the patient treatment that could have generated pressure in these areas.Therefore, it is reasonable to conclude that the reported potential deep tissue injury was not caused by pressure forces, however, meets the description, and could be better categorized, as moisture associated skin disorders (masd) instead.Moisture-associated skin damage (masd) can result when the skin has prolonged or continuous exposure to excessive moisture.Masd is a collective definition, and it has four main causes: incontinence-associated dermatitis, periwound skin damage, intertriginous dermatitis and peristomal moisture-associated dermatitis.Incontinence-associated dermatitis (iad) is predominantly a chemical irritation resulting from urine or stool coming in contact with the skin.The affected area will present with erythema, as well as maceration.The area may progress to painful partial-thickness erosions with weepy serous exudate.If left untreated, pressure and friction may increase stress on the affected area, leading to skin breakdown.To help minimize the risk of developing incontinence-associated dermatitis in at-risk patients and to minimize complications in patients already exhibiting symptoms the clinicians should minimize skin exposure to urine and stool and develop a consistent regimen of skin care.Intertriginous dermatitis (itd), also referred to as intertrigo, results from sweat being trapped in skin folds with minimal air circulation.This in turn leads to inflammation and denudation of the skin, making the area more prone to infection.The individual may report pain, itching, or burning sensations around the affected area.To help minimize the risk of developing incontinence-associated dermatitis in at-risk patients and to minimize complications in patients already exhibiting symptoms the clinicians should reduce heat and moisture within the skin folds, keep at-risk areas clean and dry.At the time of the initial report, there was no report of medical intervention required to preclude permanent impairment of a body function or permanent damage to a body structure, concluding no serious injury occurred.A masd is not considered a serious injury as it is unlikely to require medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Additionally, there was no allegation of device malfunction.An inspection of the device is pending.If any additional relevant information be received, the case will be evaluated accordingly.No further information is available on the repair of the bed at this time.Two attempts have been made to inspect the bed.The bed is continuing to be used and has not been made available for inspection.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Manufacturer Narrative

The customer reported a hospitalized patient developed a potential deep tissue injury (pdti) with use of the progressa bed and mattress.There was no allegation of a device malfunction reported.The patient in this event is a 42-year-old female.Admitting diagnosis and medical history was not provided.A purpose t pressure ulcer risk assessment was performed upon admission and the score was ¿amber¿ and no pressure damage noted.On (b)(6) 2023, the patient developed a pdti to the natal cleft.The hospital¿s turning protocol was increased from every 4 hours to every 2 hours.The tissue viability nurse (tvn) was consulted; however, the outcome of the assessment was not provided, and no medical treatment was reported.Hospital supplied bed linen was used with no report of additional materials being used under the patient.Although no malfunction of the bed was reported, the customer alleged the progressa bed contributed to the development of the pdti.Attempts to obtain additional information from the customer were unsuccessful.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.A deep tissue pressure injury (dti) is a persistent non-blanchable deep red, purple or maroon area of intact skin, non-intact skin or blood-filled blisters caused by damage to the underlying soft tissues from pressure and/or shear¿.Dti occurs in the tissue that has been subjected to pressures that exceed the tolerance level of muscle tissue.The diagnosis of dti should begin with a history of the patient's exposure to intense pressure, which leads to direct muscle damage.The specific risk profile for dti is seen during periods of ¿confinement¿ on a hard surface such as the floor following falls, ¿found down¿ events, long stays in interventional radiology or magnetic resonance imaging and even on relatively hard surfaces such as the operating room table.During events on hard surfaces, the pressure is intense enough to lead to the deformation of muscle cells leading to dtis in short periods.The potential dtis reported by the customer in this case are localised in areas (natal cleft and skin folds) that are not commonly subjected to direct pressure from the underlying bones and would unlikely be in direct contact with hard surfaces for an extended period of time.Additionally, the customer confirmed there were not any additional device(s) being used in the patient treatment that could have generated pressure in these areas.Therefore, it is reasonable to conclude that the reported potential deep tissue injury was not caused by pressure forces, however, meets the description, and could be better categorized, as moisture associated skin disorders (masd) instead.Moisture-associated skin damage (masd) can result when the skin has prolonged or continuous exposure to excessive moisture.Masd is a collective definition, and it has four main causes: incontinence-associated dermatitis, periwound skin damage, intertriginous dermatitis and peristomal moisture-associated dermatitis.Incontinence-associated dermatitis (iad) is predominantly a chemical irritation resulting from urine or stool coming in contact with the skin.The affected area will present with erythema, as well as maceration.The area may progress to painful partial-thickness erosions with weepy serous exudate.If left untreated, pressure and friction may increase stress on the affected area, leading to skin breakdown.To help minimize the risk of developing incontinence-associated dermatitis in at-risk patients and to minimize complications in patients already exhibiting symptoms the clinicians should minimize skin exposure to urine and stool and develop a consistent regimen of skin care.Intertriginous dermatitis (itd), also referred to as intertrigo, results from sweat being trapped in skin folds with minimal air circulation.This in turn leads to inflammation and denudation of the skin, making the area more prone to infection.The individual may report pain, itching, or burning sensations around the affected area.To help minimize the risk of developing incontinence-associated dermatitis in at-risk patients and to minimize complications in patients already exhibiting symptoms the clinicians should reduce heat and moisture within the skin folds, keep at-risk areas clean and dry.At the time of the initial report, there was no report of medical intervention required to preclude permanent impairment of a body function or permanent damage to a body structure, concluding no serious injury occurred.A masd is not considered a serious injury as it is unlikely to require medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Additionally, there was no allegation of device malfunction.An inspection of the device is pending.If any additional relevant information be received, the case will be evaluated accordingly.14aug2023 clinical evaluation update: multiple attempts have been made by hillrom to inspect the device; however, the device has not been made available for inspection and the bed continues to be used for patient care by the customer.Based on this information, no further action is required.

Event Description

The customer reported a hospitalized patient developed a potential deep tissue injury (pdti) with use of the progressa bed and mattress.There was no allegation of a device malfunction reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: PROGRESSA FRAME
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17413747
• MDR Text Key: 320152657
• Report Number: 1824206-2023-00836
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P7500A001494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/23/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Female