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

Model Number P7500A001475

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 04/11/2023

Event Type  Injury  

Event Description

The customer contributes an upsurge of pressure injuries ranging from stage 1 to stage 3 to the use of the progressa bed.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

It was initially reported that the customer contributes an upsurge in the presence of pressure injures to the use of the progressa bed.Follow-up with the customer determined that the patient associated with this bed ((b)(6)) was reported to have stage 2 sacrum, stage 3 left buttock, stage 1 right buttock ((b)(6) 2023), stage 2 coude ((b)(6) 2023) and stage 3 elbow ((b)(6) 2023) pressure injuries.Medical intervention was not reported.Additionally, specific details of the event including clarification if the associated pressure injury were preexisting, or the patient¿s medical history were not provided.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.Additionally, the instructions for use (ifu) states the therapy surface is not a substitute for good nursing practices.Therapy modes should be used in conjunction with good assessment and protocol.Failure to follow good nursing practices may result in patient harm.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.Additionally, the device instructions for use (ifu) states the therapy surface is not a substitute for good nursing practice and the device therapy modes should be used in conjunction with good assessment and protocol.Stage 1 pressure injury is characterized by reddening of the skin that does not blanch when touched/pressed.Partial-thickness skin loss no deeper than the dermis and can include intact or ruptured blisters.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 stage 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 3 pressure injury is categorized as full-thickness tissue loss.Subcutaneous fat may be visible, but bone, tendon or muscle are not exposed.A stage 3 pressure injury often requires medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure and therefore meets the definition of a serious injury.At this time, the device inspection is pending, as the reported bed remains in patient use and the customer has not made the device available for inspection.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 contributes an upsurge of pressure injuries ranging from stage 1 to stage 3 to the use of the progressa bed.Specific details of the event including clarification if the associated pressure injury were preexisting, the medical treatment provided for the pressure injury, the patient¿s medical history, accessory devices utilized, and facilities positioning protocols were not provided.This report is in reference to a possible reportable malfunction for the progressa bed with the serial: (b)(6).Follow-up with the customer determined that the patient associated with this bed (b)(6) was reported to have stage 2 sacrum, stage 3 left buttock, stage 1 right buttock on (b)(6) 2023), stage 2 coude on (b)(6) 2023) and stage 3 elbow on (b)(6) 2023) pressure injuries.Medical intervention was not reported.Additionally, specific details of the event including clarification if the associated pressure injury were preexisting, or the patient¿s medical history were not provided.The hillrom technician thoroughly evaluated the bed from the event reported by the customer.It was confirmed that the bed was functioning correctly and in accordance with the technical manual: no error codes.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, pressure ulcers, or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.Additionally, the instructions for use (ifu) states the therapy surface is not a substitute for good nursing practices.Therapy modes should be used in conjunction with good assessment and protocol.Failure to follow good nursing practices may result in patient harm.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.Additionally, the device instructions for use (ifu) states the therapy surface is not a substitute for good nursing practice and the device therapy modes should be used in conjunction with good assessment and protocol.A stage 1 pressure injury is characterized by reddening of the skin that does not blanch when touched/pressed.Partial-thickness skin loss no deeper than the dermis and can include intact or ruptured blisters.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 stage 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 3 pressure injury is categorized as full-thickness tissue loss.Subcutaneous fat may be visible, but bone, tendon or muscle are not exposed.A stage 3 pressure injury often requires medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure and therefore meets the definition of a serious injury.In this event, based on the report of a stage 3 pressure injury, indicates the occurrence of a serious injury.The root cause of the reported pressure injuries is unknown due to the sparsity of details provided.The inspection of the device notes the bed to be functioning as designed and noted pressure to be within appropriate range, thus ruling out a device malfunction.

Event Description

The customer contributes an upsurge of pressure injuries ranging from stage 1 to stage 3 to the use of the progressa bed.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: maritza valencia ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16889671
• MDR Text Key: 314806072
• Report Number: 1824206-2023-00376
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: P7500A001475
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2020
• 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 Outcome(s): Other