MAUDE Adverse Event Report: HILL-ROM, INC. TC BARIATRIC BED; A/C POWERED ADJUSTABLE HOSPITAL BED

Model Number 1840

Device Problem Inflation Problem (1310)

Patient Problem Ulcer (2274)

Event Date 02/24/2015

Event Type  Injury  

Event Description

Hill-rom received a report from the account stating the seat section of the air mattress would not inflate.The bed was located in icu-3 at the account.There was a report of a patient that had a preexisting wound that had previous flap surgeries, which developed into a stage 3 ulcer.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The hill-rom tech found the weigh frame junction board had a loose connection.The tech replaced the weigh frame junction board to resolve the issue.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: TC BARIATRIC BED
• Type of Device: A/C POWERED ADJUSTABLE HOSPITAL BED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: tony werner ; 1069 state rte 46 e; batesville, IN 47006 ; 8129312359
• MDR Report Key: 4643657
• MDR Text Key: 5612401
• Report Number: 1824206-2015-00418
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122473
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 1840
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2007
• 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: 38 YR
• Patient Weight: 113