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

Model Number P0819A

Device Problem Use of Device Problem (1670)

Patient Problem Pressure Sores (2326)

Event Date 03/16/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that an envella ¿did not have a lot of flow through the beads¿ and the patient developed a stage pressure injury 3 to their coccyx approximately three weeks after being placed on the device.The injury required medical intervention of dressing changes by wound care team.The patient is a 27-year-old female, weighing 67kg.Admitted for an acute kidney injury.It is noted she had bilateral stage 4 pressure injuries to her buttocks upon admission.Additionally, the nurse states the patient was non-complaint with turning, wears briefs and refuses changing of the briefs.Staff have encouraged and offered other forms of incontinence maintenance however the patient has refused.There were no audible/visual messages/alerts from the device and no delay in patient care due to the event.Device inspection was requested from the customer.The envella air fluidized therapy system is intended for medical purposes to help treat or prevent pressure injuries, to treat severe or extensive burns, or to aid in circulation.This bed is ideal support for patients who have advanced pressure injuries, flaps, grafts, or burns, and require frequent transfers or variable head elevation, and any other conditions appropriate for air fluidized therapy.A hillrom technician promptly completed a bed swap for the customer and the device in question was returned to hillrom for inspection.Inspection found the diffuser board was bad therefore not a lot of airflow was unable to occur with the device.Development of pressure ulcers is multifactorial and cannot be only attributed to performance of the surface.Risk factors include protein-calorie malnutrition, microclimate (skin wetness caused by sweating or incontinence), diseases that reduce blood flow to the skin, such as arteriosclerosis, or diseases that reduce the sensation in the skin, such as paralysis or neuropathy.Position changes are key to pressure sore 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.A stage 3 pressure injury is defined as full thickness tissue loss.Subcutaneous fat may be visible, but the bone, tendon or muscle are not exposed.Treatment may include prescribed antibiotic therapy and at times removal of any dead tissue to help promote healing and prevent or treat infection.For this event, a serious injury occurred (stage 3 pi) and additionally the device inspection found a malfunctioning diffuser board.Additionally, patient non-compliance with the customer¿s wound care prevention interventions may likely to have also contributed to the serious injury.Based on this information, no further action is required.

Event Description

It was reported that an envella ¿did not have a lot of flow through the beads¿ and the patient developed a stage 3 pressure injury to their coccyx approximately three weeks after being placed on the device.The injury required medical intervention of dressing changes by wound care team.Additionally, the nurse states the patient was non-complaint with turning, wears briefs and refuses changing of the briefs.Staff have encouraged and offered other forms of incontinence maintenance however the patient has refused.There were no audible/visual messages/alerts from the device and no delay in patient care due to the event.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: brad wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 16725297
• MDR Text Key: 313166689
• Report Number: 1824206-2023-00239
• Device Sequence Number: 1
• Product Code: INX
• UDI-Device Identifier: 00887761013834
• UDI-Public: 010088776101383411190829
• 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: 04/12/2023

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: 03/16/2023
• Initial Date FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2019
• 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
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 67 KG