MAUDE Adverse Event Report: HILL-ROM BATESVILLE CLINITRON RITE HITE - REFURB; BED, AIR FLUIDIZED

Model Number P0800010019RFB

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem Pressure Sores (2326)

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

The patient's wound is being treated daily by the patient's personal care assistant with a saline solution, amerigel cream and an allevyn patch.The patient also scheduled an appointment with a wound care clinic.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.The hill-rom technician replaced the blower box assembly to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the patient stating he developed a new pressure ulcer that progressed to a stage 3 while the clinitron bed was giving a manifold pressure error and shutting down.The bed was located in the patient's home.This report was filed in our complaint handling system as (b)(4).

• Brand Name: CLINITRON RITE HITE - REFURB
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 6096566
• MDR Text Key: 59756842
• Report Number: 1824206-2016-00484
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Nursing Assistant
• Type of Report: Initial
• Report Date: 10/20/2016

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 Operator: Lay User/Patient
• Device Model Number: P0800010019RFB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2016
• Initial Date FDA Received: 11/11/2016
• 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