MAUDE Adverse Event Report: HILL-ROM, INC. VERSACARE BED; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number 3200

Device Problem Inflation Problem (1310)

Patient Problem Pressure Sores (2326)

Event Date 04/08/2014

Event Type  Other  

Event Description

Hill-rom received a report from the account stating the bed is not inflating properly.The bed is located in the patient's home.The account stated the patient is developing bed sores on the left heel.This report was filed in our complaint handling system as complaint number (b)(4).The reported injury is serious in nature per fda definition; however, there was no evidence of a malfunction and the device performed as intended.The pressure ulcer was related to the patient's underlying condition.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.Based on this information, no further action is required.

Manufacturer Narrative

The account requested hill-rom to evaluate the bed to make sure it is functioning properly.The service technician investigation indicated that there was no evidence of a malfunction he found the bed functioned as designed.Margaret peterson, the patient's wife, stated (b)(6) is (b)(6) tall and his feet hung off of their old bed.They purchased the versacare bed so it can accommodate how tall the patient is.Because of this, she stated she did not watch the condition of his whole body as closely as she should have.She stated that (b)(6) had flap surgery 3 years ago on his left ischium and since then he lays predominantly on his right side.As a result, the way his legs come together, this puts more pressure on the left heel.She stated that a doctor came to the home to treat the wound.He debrided the wound and instructed her on how to properly monitor and treat the wound.At the time the doctor was there, the wound measured at 3.5 cm diameter with an eschar measuring 2.5 cm and necrotic tissue around the edge.Since then, she stated the wound is healing and looking better.It has pink skin around the edges and bleeds freely when she cleans it.

• Brand Name: VERSACARE BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 3807952
• MDR Text Key: 17385617
• Report Number: 1824206-2014-01411
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 04/08/2014

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?: Yes
• Device Operator: Other
• Device Model Number: 3200
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/08/2014
• Initial Date FDA Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 132