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

Model Number P0819A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 04/20/2023

Event Type  Injury  

Event Description

It was reported that approximately one month after being placed on an envella bed, the patient developed a deep tissue pressure injury (dtpi) to their right lateral foot.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

It was reported that approximately one month after being placed on an envella bed, the patient developed a deep tissue pressure injury (dtpi) to their right lateral foot.Medical intervention included mepilex to the wound and a heel boot.The patient is a 68-year-old paraplegic male, weighing 81 kg.With a relevant history of osteomyelitis and was admitted for flap surgery of a pressure injury to his buttocks.Follow up with his nurse notes the patient stated he feels the bed is ¿not big enough and does not relieve pressure.¿ the foot support cushion accessory was therefore removed by staff for comfort measures.Per the facility protocol for flap surgery, the patient is to be kept flat with no turning for 6 weeks.The bed was noted to be in regular mode, no audible/visual messages/alerts, and no sheets present.The patient has remained on the device and an inspection was requested.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.The foot support cushion is a device accessory that helps to provide support and stability for the patient¿s feet.Inspection of the device by a hillrom technician found the bed to be functioning as designed.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.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 treatment may include prescribed antibiotic therapy and removal of dead tissue to promote healing and prevent or treat infection.In some cases, dtpi could resolve in few days, becoming a stage 1 or 2 pressure injury 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.For this event, inspection found no malfunction.However, despite limited information provided on the patient¿s dtpi staging, the patient received medical intervention to preclude permanent impairment of body function or damage to a body structure (mepiplex), indicating a serious injury occurred.Causality is likely multifactorial due to patient¿s immobility and requirement to remain without turning for 6-week flap protocol.However, due to patient report that the bed isn¿t big enough and doesn¿t relieve pressure, and the removal of the foot support accessory, at this time we are unable to exclude the foot support contributed to the si.If any new relevant information is received the complaint will be addressed accordingly.Based on this information, no further action is required.

• 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: maritza valencia ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16824726
• MDR Text Key: 314106528
• Report Number: 1824206-2023-00330
• Device Sequence Number: 1
• Product Code: INX
• UDI-Device Identifier: 00887761013834
• UDI-Public: 010088776101383411190322
• 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: 04/27/2023

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: 04/20/2023
• Initial Date FDA Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2019
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 81 KG