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

Model Number P0800010016

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Pressure Sores (2326)

Event Date 04/10/2017

Event Type  Injury  

Manufacturer Narrative

The bed stopped fluidizing properly and the caregivers moved the patient off the bed.The caregivers could not confirm the stage of the pressure ulcers when the patient was moved off the bed.After being removed from the clinitron bed, the pressure ulcers continued to worsen to their current stage 4.The patient goes to a wound clinic and has daily nursing care in her home.The wounds are being treated with a wound cleanser followed by a dry, silver-based prisma powder.Optifoam pads are then applied and covered with bandages.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 hill-rom technician is being dispatched to repair the bed.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the patient's two pressure ulcers on her buttocks worsened to a stage 4.The bed was located in the patient's personal residence.This report was filed in our complaint handling system as (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: 6589178
• MDR Text Key: 75889636
• Report Number: 1824206-2017-00204
• 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: Other
• Type of Report: Initial
• Report Date: 04/10/2017

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: Other Caregivers
• Device Model Number: P0800010016
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 05/24/2017
• 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 Age: 54 YR
• Patient Weight: 73