MAUDE Adverse Event Report: HILL-ROM BATESVILLE CLINITRON AT*HOME; BED, AIR FLUIDIZED

Model Number P0800010016

Device Problem Pressure Problem (3012)

Patient Problem Pressure Sores (2326)

Event Date 05/22/2017

Event Type  Injury  

Manufacturer Narrative

The hill-rom technician found the bed's sheet was unzipped due to the inside bladder's age not allowing the new sheet to seal properly.The technician also found the blower was weak and not providing enough airflow to allow proper fluidization or the airwall to fully inflate.Per the hill-rom user manual, poor fluidization; if fluidization is sluggish or uneven, notify your hill-rom representative.Fluidization is affected by the following: room temperature, humidity, the amount of materials, such as fluid, cells or cellular debris, which has escaped from the blood vessels and has been deposited in tissues or on tissue surfaces, restricted air circulation from blankets on the bed.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.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2014.It is unknown if the patient had any other preventative maintenance performed on this bed.Insurance approval of repair of the bed has been requested but not yet received.The hill-rom technician will repair the bed once insurance approval of the repair is received.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the patient stating he has a pre-existing wound on his coccyx for the past four years that has worsened (he is unsure of the stage, but believes it is a stage 4).The wound is being debrided and then covered with "silver" cream and a gauze patch.The wound is not yet improving.The patient sleeps approximately half of the nights on the clinitron bed and half of the nights on an air mattress.The patient spends the days in his wheel chair on a gel pad.This report was filed in our complaint handling system as complaint #(b)(4).

• 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: 6638337
• MDR Text Key: 77497384
• Report Number: 1824206-2017-00248
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/22/2017

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: P0800010016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/13/2017
• 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
• Patient Age: 57 YR
• Patient Weight: 64