MAUDE Adverse Event Report: HILL-ROM BATESVILLE PROGRESSA FRAME; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number P7500A000742

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pressure Sores (2326); Injury (2348)

Event Date 05/11/2016

Event Type  Injury  

Manufacturer Narrative

No further information is available on the repair of the bed at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.It is unknown if the facility performed any other preventative maintenance on this bed.The wound is being treated with ointments and dressings.The patient is in the bed full time.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.

Event Description

The account reported to hill-rom that a patient had a pre existing deep tissue injury on her left buttocks that developed into an unstagable wound.The bed was located at the account.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: PROGRESSA FRAME
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 812931-235
• MDR Report Key: 5694619
• MDR Text Key: 46393799
• Report Number: 1824206-2016-00245
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: P7500A000742
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other