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

Model Number P7500A001677

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

Patient Problem Pressure Sores (2326)

Event Date 12/30/2021

Event Type  malfunction  

Event Description

The customer initially reported experiencing grade 3/grade 4 pressure injuries among 13 patients with the use of the hillrom progressa bed.Follow up with the customer found that 7 patients were reported to have developed pressure injuries with use of the progressa bed.Each reported injury will be evaluated separately (patient 1-7).This evaluation is for patient 1, a (b)(6) year old male with a history of cardiac surgery and alveolar hemorrhage.It is noted this patient was admitted to the icu for 32 days and developed a stage 2 sacral and abdominal pressure injury.Medical intervention for the patient's pressure injuries included mepentol oli, purilon, mepilex and varihesive.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

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 stage 2 pressure injury is characterized by partial-thickness skin loss no deeper than the dermis and can include intact or ruptured blisters.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 2 pressure injury is considered to be a moderate injury and does not meet the definition of a serious injury or a serious deterioration in health.However, the functionality of this device could not be determined at the time of this evaluation as the investigation is ongoing.If this device were determined to have malfunctioned serious injury could occur.Therefore hillrom is cautiously reporting this event due to the potential for serious injury.No further information is available on the device at this time.The device is going to be inspected onsite by a hrc technician.Hillrom will submit a final report with investigation conclusion on this incident.

Manufacturer Narrative

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.The bed and surface has been thoroughly inspected by the hrc technician and it was confirmed that the bed is functioning correctly and in accordance with the technical manual.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.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 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 2 pressure injury is considered to be a moderate injury and does not meet the definition of a serious injury or a serious deterioration in health.A stage 2 pressure injury is considered to be a moderate injury and does not meet the definition of a serious injury or a serious deterioration in health.There was no malfunction of the device, no serious injury or serious deterioration in the state of health associated with this event.Therefore hillrom does not consider this event reportable.

Event Description

The customer initially reported experiencing grade 3/grade 4 pressure injuries among 13 patients with the use of the hillrom progressa bed.Follow up with the customer found that 7 patients were reported to have developed pressure injuries with use of the progressa bed.Each reported injury will be evaluated separately (patient 1-7).This evaluation is for patient 1, a 59-year old male with a history of cardiac surgery and alveolar hemorrhage.It is noted this patient was admitted to the icu for 32 days and developed a stage 2 sacral and abdominal pressure injury.Medical intervention for the patient's pressure injuries included mepentol oli, purilon, mepilex and varihesive.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: sarah oreilly ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 13368894
• MDR Text Key: 286647942
• Report Number: 1824206-2022-00037
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00887761000100
• UDI-Public: 010088776100010011211030
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P7500A001677
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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: 59 YR
• Patient Sex: Male