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 11/20/2014

Event Type  Injury  

Event Description

The customer alleged the mattress was not inflating properly.The seat section was deflated to the metal frame and the patient wounds are worsening.The patient is currently treated daily with dressing and ointments.Wound care also comes once a week.The wounds have gotten so bad the patient has plastic surgery on his backside.The bed was located in the patient's home.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

Hill rom technician found the unit operating as designed.Confirmed there was no malfunction with the device.The reported injury is serious in nature per fda definition.However, there was no evidence of a malfunction and the device performed as intended.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 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.

• Brand Name: VERSACARE BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM INC.; batesville IN
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 4377186
• MDR Text Key: 5265489
• Report Number: 1824206-2014-02854
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 3200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2012
• 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
• Patient Age: 70 YR
• Patient Weight: 113