MAUDE Adverse Event Report: CLINITRON AT HOME; NONE

Model Number 0800

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 09/21/2014

Event Type  Injury  

Event Description

Hill-rom received a report from the account that the bed was alarming and the pt's pre-existing pressure sore is getting worse.The pt stated the wound on her coccyx has deepened to expose her spinal bone.The bed was located in the pt's home.This report was filed in our complaint handling system as complaint (b)(4).

Manufacturer Narrative

The hill-rom tech found the zone 3 proportional valve was worn.The tech replaced the proportional valve to resolve the issue.No add'l treatment was needed.Pt continued with currently therapy.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: CLINITRON AT HOME
• Type of Device: NONE
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 4202285
• MDR Text Key: 5039793
• Report Number: 1824206-2014-02484
• 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,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/21/2014

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: 09/21/2014
• Initial Date FDA Received: 10/16/2014
• 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
• Patient Age: 72 YR