MAUDE Adverse Event Report: HILL-ROM BATESVILLE ENVISION BLOWER KIT; BED FLOTATION THERAPY POWERED

Model Number P136026

Device Problem Connection Problem (2900)

Patient Problem Pressure Sores (2326)

Event Date 11/21/2016

Event Type  Injury  

Manufacturer Narrative

The pressure wound was treated with dakins solution and abdominal pads.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 blower connection was not properly attached causing the blower to not function as designed.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this blower in august 2016.It is unknown if the facility performed any other preventative maintenance on this blower.The technician properly connected the blower to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the patient developed a pressure ulcer on his sacrum that progressed to stage 4.The blower was located at the account.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: ENVISION BLOWER KIT
• Type of Device: BED FLOTATION THERAPY POWERED
• 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: 6186387
• MDR Text Key: 62746687
• Report Number: 1824206-2016-00532
• Device Sequence Number: 1
• Product Code: IOQ
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: P136026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2016
• 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