MAUDE Adverse Event Report: HILL-ROM, INC. CLINITRON BED; BED, AIR FLUIDIZED

Model Number 0800

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Pressure Sores (2326)

Event Date 03/04/2015

Event Type  Injury  

Event Description

Hill-rom received a report from the patient stating they felt some hard plastic in the bed and have developed a stage 3 wound on his sacrum.The wound was treated with gauze packing and a wound vac was ordered during his last wound clinic visit.The bed was located in the patient's home at the time of the incident.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The hill-rom technician found the filter sheet tie down straps had come loose allowing the zip lock seal to raise.The technician tightened the tie downs to resolve the issue.The filter sheet tie downs can become loose from patient movement, removal or being placed in the bed.If this were to recur, the resolution could be easily handled by the caregiver.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.

• Brand Name: CLINITRON BED
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 4662277
• MDR Text Key: 5605835
• Report Number: 1824206-2015-00448
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/04/2015

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: Other
• Device Model Number: 0800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/04/2015
• Initial Date FDA Received: 04/01/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 98