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 Pressure Sores (2326)

Event Date 07/26/2022

Event Type  Injury  

Manufacturer Narrative

The customer reported a stage 2 pressure injury to the patient's left sacrum and a stage 3 to the gluteal fold while on an envella bed.The customer notes the middle section of the device was functioning properly, however the outer perimeter of the bed remained hard.Medical intervention included foam dressings and there was confirmation of no delay in treatments or procedures.The patient was on the device from (b)(6) 2022, with the two pressure injures were noted on (b)(6) 2022.The customer states the device was in regular pressure mode and it was unknown if any audible/ visual messages were noted.The bed was used with fitted sheets, 1 disposable pad and medix to bilateral heels, and the care team states they were turning every 2 hours.The patient is a 65-year-old female, weighting 75 kg.Admitted for 5.5% tbsa full thickness flame burns to face, neck, anterior, posterior trunk, and bilateral upper extremities, with a past medical history of hypothyroidism, htn, bipolar disorder, high cholesterol, covid pna with sepsis (b)(6) 2022.The customer states the patient¿s injuries were healing prior to discharge.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.Inspection of the device by a hillrom technician found, a repair was made on (b)(6) 2022, for power cord damage.Bpi was performed on (b)(6) 2022 and passed with no issues (good air fluidization of microspheres).Bed is currently 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.A stage 2 pressure injury is considered a moderate injury as it does not meet the definition of serious injury as it is not life threatening; does not result in permanent impairment of a body function or permanent damage to a body structure; and any application of dermal creams or coverings does not constitute medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.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.Although the device was noted to be functioning as designed; hillrom/baxter deems this a reportable event due to the serious injury involved.Based on this information, no further action is required.

Event Description

The customer reported a stage 2 pressure injury to the patient's left sacrum and a stage 3 to the gluteal fold while on an envella bed.The customer notes the middle section of the device was functioning properly, however the outer perimeter of the bed remained hard.Medical intervention included foam dressings and there was confirmation of no delay in treatments or procedures.The patient was on the device from (b)(6) 2022, with the two pressure injures were noted on (b)(6) 2022.The bed was located at the account.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: 15223970
• MDR Text Key: 297871860
• Report Number: 1824206-2022-00364
• Device Sequence Number: 1
• Product Code: INX
• UDI-Device Identifier: 00887761013834
• UDI-Public: 010088776101383411170301
• 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: 08/15/2022

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: 07/26/2022
• Initial Date FDA Received: 08/15/2022
• 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 Outcome(s): Other