MAUDE Adverse Event Report: HILL-ROM BATESVILLE ENVELLA BED; BED, AIR FLUIDIZED

Model Number P0819A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/11/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that the envella bed stopped fluidizing and the patient developed three deep-tissue injuries (dti).This patient has a history of spinal cord injury and wound vacs for wounds in the ischial/sacral area that have "been in place for two weeks prior" to this event.Additionally, the patient was reported to have "lots of trouble with pressure injuries." during a follow-up call with the customer, the customer reported that at the time of the event, the caregiver was present with the patient, and the bed began to alarm "error-blower (fan error)." the caregiver unplugged the bed and plugged it back in, in an attempt to resolve the issue, however, the issue did not resolve.The patient was then moved to a different bed.The customer reported that dressing changes at this facility occur on mondays, wednesdays, and fridays and that on the friday prior to the event, there was no documentation that the patient had a dti.The dti's were noted during monday's dressing change, one day following the alarm.Staging or wound characteristics were not provided by the customer.Additionally, medical intervention required for the patient's dti's was not reported.The use of the envella bed is intended to help treat or prevent pressure injuries, treat severe or extensive burns, or aid in circulation.The bed¿s fluidization system, in the lower portion of the bed, is composed of microspheres (beads) put in motion by the bed¿s air system causing the beads to take on the properties of fluid that the patient¿s body can float in.The bed is equipped with an alert system that generates audible and visual indicators to notify the caregiver of potentially hazardous conditions with the intention that the caregiver will respond to the alert and take appropriate action to rectify the issue.The ifu states that in the event of a fan error, "air fluidization turns off because of a fan malfunction, a triple beep sounds every 5 seconds and a message shows on the gci (graphical caregiver interface).Remove the patient from the bed and contact hillrom." the customer was instructed by a hillrom technician to unplug the bed, and plug the bed back in.It is noted that following those actions "the bed computer rebooted and fluidization is now functioning as designed." the development of pressure injuries is multifactorial and cannot only be attributed to the performance of the surface or the pro plus mattress.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.Deep tissue pressure injuries (dtpi) are persistent non-blanchable deep red, purple or maroon areas of intact skin, non-intact skin or blood-filled blisters caused by damage to the underlying soft tissues.Treatment can include frequent repositioning off the site of injury, good skin care, proper support surface selection, correcting any systemic issues or nutritional deficiencies and medical treatment from a wound care specialist.At times additional treatments can include prescribed antibiotic therapy and removal of dead tissue to promote healing and prevent or treat infection.In some cases, dti could resolve in few days, becoming pi stage 1 or 2 once they appear on the external layers of the skin.In other cases, they could develop into stage 3 or 4 (or unstageable) depending on the involvement of deeper underlying structure.In this event, this patient was reported to have preexisting pressure injury "problems" including preexisting wounds with wound vacs in the same area as identified by the customer.Due to the facility's dressing change schedule, it is unclear if the reported dti's developed during the timeframe of post-friday dressing change, but prior to the bed's alert, or after the patient was removed from the envella bed altogether.However, based on the patient's pressure injury history along with wound vac intervention, it is reasonable to conclude that the dtis reported with this event will require or be provided the same intervention, and thus are considered a serious injury.Of note, the bed provided an appropriate alert, as acknowledged by the customer, and worked as designed to notify the caregiver to take appropriate action.Based on this information, no further action is required.

Event Description

It was reported that the envella bed stopped fluidizing and the patient developed three deep-tissue injuries (dti).This patient has a history of spinal cord injury and wound vacs for wounds in the ischial/sacral area that have "been in place for two weeks prior" to this event.Additionally, the patient was reported to have "lots of trouble with pressure injuries." during a follow-up call with the customer, the customer reported that at the time of the event, the caregiver was present with the patient, and the bed began to alarm "error-blower (fan error)." the caregiver unplugged the bed and plugged it back in, in an attempt to resolve the issue, however, the issue did not resolve.The patient was then moved to a different bed.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: ENVELLA BED
• Type of Device: BED, AIR FLUIDIZED
• 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: 16086980
• MDR Text Key: 306533408
• Report Number: 1824206-2023-00001
• Device Sequence Number: 1
• Product Code: INX
• UDI-Device Identifier: 00887761013834
• UDI-Public: 010088776101383411190208
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: P0819A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2022
• Initial Date FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2019
• 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