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

Model Number P7500A001494

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 12/12/2023

Event Type  Injury  

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 incident was captured under hillrom complaint ref # (b)(4).

Manufacturer Narrative

The patient in this event is a 44-year-old female weighing 68 kg and measuring 5¿3¿ in height.The patient was admitted to the unit on (b)(6) 2023 and was intubated/ventilated requiring 12-hour proning.A purpose t assessment was performed upon admission with a score of ¿amber¿ and no pressure damage noted.On 12dec2023, the tissue viability nurse (tvn) was consulted, per protocol, for the development of a pdti to the patient¿s right toe post-proning; however, the outcome of the assessment was not provided, and no treatment was reported.The hospital¿s turning protocol was reported as every 4 hours.Hospital supplied bed linen was used in addition to incontinence pads under the patient.Although no malfunction of the bed was reported, the customer alleged the progressa bed contributed to the development of the pdti.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.In some cases, a dti can resolve in a few days, becoming pi stage 1 or 2 once they appear on the external layers of the skin.In other cases, they can develop into stage 3 or 4 (or unstageable) depending on the involvement of deeper underlying structure.In this event, there was no report of medical intervention required at the time of the initial report.However, the outcome of the tvn assessment was not provided and there is no confirmation that the dti resolved.Therefore, the reported pdti of the right toe is considered a serious injury for the reasons stated above.An inspection of the device is pending.If additional relevant information is received, the case will be reassessed accordingly.

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 44-year-old female weighing 68 kg and measuring 5¿3¿ in height.The patient was admitted to the unit on (b)(6) 2023 and was intubated/ventilated requiring 12-hour proning.A purpose t assessment was performed upon admission with a score of ¿amber¿ and no pressure damage noted.On (b)(6) 2023, the tissue viability nurse (tvn) was consulted, per protocol, for the development of a pdti to the patient¿s right toe post-proning; however, the outcome of the assessment was not provided, and no treatment was reported.The hospital¿s turning protocol was reported as every 4 hours.Hospital supplied bed linen was used in addition to incontinence pads under the patient.Although no malfunction of the bed was reported, the customer alleged the progressa bed contributed to the development of the pdti.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.In some cases, a dti can resolve in a few days, becoming pi stage 1 or 2 once they appear on the external layers of the skin.In other cases, they can develop into stage 3 or 4 (or unstageable) depending on the involvement of deeper underlying structure.In this event, there was no report of medical intervention required at the time of the initial report.However, the outcome of the tvn assessment was not provided and there is no confirmation that the dti resolved.Therefore, the reported pdti of the right toe is considered a serious injury for the reasons stated above.An inspection of the device is pending.If additional relevant information is received, the case will be reassessed accordingly.31jan2024, clinical evaluation update: baxter has made multiple attempts to inspect the bed; however, the bed was unavailable for inspection due to continued use.A device malfunction cannot be ruled out at this time.

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 incident was captured under hillrom complaint ref: (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: 18450497
• MDR Text Key: 332172775
• Report Number: 1824206-2024-00011
• 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: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: P7500A001494
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 68 KG