MAUDE Adverse Event Report: HILL-ROM, INC. CLINITRON BED; BED, AIR FLUIDIZED

Model Number 0800

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem Injury (2348)

Event Date 12/12/2014

Event Type  Injury  

Event Description

Hill-rom received a report from the account stating the unit was alarming and shutting down.The pt developed stage 3 wounds and was admitted to the hosp.The bed was located at the account.There was a pt injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

Manufacturer Narrative

The hill-rom tech found the care givers placed an egg crate foam under the pt which left her on the hard surface, which would have contributed to further skin break down.The tech also found the bed had heater failures.Also had a hole in bottom bladder cover at head section causing bead leak and several other worn areas.Filter sheet badly stained as well.Further assessment found that the diffuser board was clogged, heavily soiled beads, and bad cable assembly temperature cutoff which caused the heater failure.The technician replaced the failed parts 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.A search of the hill-rom maintenance records did not show hill-rom performed any preventive maintenance on this bed.It is unk if the facility performs preventive maintenance on its beds.

• Brand Name: CLINITRON BED
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 4417020
• MDR Text Key: 17579475
• Report Number: 1824206-2015-00058
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2014

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
• Device Model Number: 0800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2014
• Initial Date FDA Received: 01/09/2015
• 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