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

Model Number P3200K000369

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pressure Sores (2326)

Event Date 03/23/2022

Event Type  Injury  

Manufacturer Narrative

It was initially reported that a home used versacare was having mattress depression issues and the patient was concerned that his two pre-existing backside wounds could worsen.The patient has a medical history of being quadriplegic.He states he does have a pre-existing wound to his left ischial (reports having over a two-year period), however he did develop a new pressure injury to his right ischial, stage 3 or 4 during the time when the bed was having issues.No alarms/ alerts were noted from the device.The patient states he went to the clinic for treatment and is currently doing home care with improvements being seen.He additionally states the home used bed is 10 years of age and hillrom technicians have inspected the device and the issue has been resolved.The versacare p500 surface is an easy to use, wound care solution that can help meet patients¿ diverse needs.This surface can help reduce pressure ulcer prevalence by addressing the key factors attributed to skin breakdown: pressure, friction, shear, and moisture.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.Stages 3 and 4 pressure ulcers have deep involvement of underlying tissue with more extensive destruction.Stage 3 involves the full thickness of the skin and may extend into the subcutaneous tissue layer; granulation tissue and epibole (rolled wound edges) are often present.At this stage, there may be undermining and/or tunneling that makes the wound much larger than it may seem on the surface.Stage 4 pressure ulcers are the deepest, extending into the muscle, tendon, ligament, cartilage or even bone.The goal of treatment for stage 3 and 4 pressure ulcers, is to properly debride and dress the wound cavity, create or maintain moisture for optimal healing, and protect the wound from infection.Although the device was noted to be functioning as designed; hillrom deems this a reportable event due to the serious injury of a stage 3 or 4 pressure injury involved.Based on this information, no further action is required.

Event Description

It was initially reported that a home used versacare was having mattress depression issues and the patient was concerned that his two pre-existing backside wounds could worsen.The patient has a medical history of being quadriplegic.He states he does have a pre-existing wound to his left ischial (reports having over a two-year period), however he did develop a new pressure injury to his right ischial, stage 3 or 4 during the time when the bed was having issues.No alarms/ alerts were noted from the device.The patient states he went to the clinic for treatment and is currently doing home care with improvements being seen.He additionally states the home used bed is 10 years of age and hillrom technicians have inspected the device and the issue has been resolved.

• Brand Name: VERSACARE 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: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 14106604
• MDR Text Key: 289228155
• Report Number: 1824206-2022-00201
• Device Sequence Number: 1
• Product Code: FNL
• 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: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: P3200K000369
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2011
• 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