MAUDE Adverse Event Report: HILL-ROM, INC. ECLIPSE ASSEMBLY; BED FLOTATION THERAPY POWERED

Model Number 0800

Device Problem Insufficient Information (3190)

Patient Problem Pressure Sores (2326)

Event Date 04/29/2014

Event Type  Other  

Event Description

The consumer reported he developed a pressure sore that he believes was caused by the mattress not functioning properly.The mattress is located in the patient's home.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The hill-rom technician performed the investigation and the caregiver estate the hip section of air mattress loses air pressure when the patients head section is elevated causing the patient to fall to his right side.The patient was treated in hospital for bed sores.The technician inspected the unit and found the zone 3 proportional valve had low pressure with a reading of 6.7.No service light came on while inspecting the bed.The technician restarted the unit and checked pressure and unit is now functioning as designed.A hill-rom representative called and spoke with the patient to ask about the allegation of a new pressure sore developing.The patient stated that the bed was not functioning correctly and he has developed a new sore on his left side.The patient did seek medical treatment and his sore is a stage 4 pressure ulcer.He was given medicine and a 6 week iv.The patient confirmed he has suffered from preexisting pressure ulcers and has had surgery on them.The hill-rom representative inservice the patient on the importance of patient positioning to ensure proper air flow during use of the mattress.The reported injury is serious in nature per fda definition.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), disease that reduce blood flow to the skin, such as arteriosclerosis, or diseases that reduce the sensation in the skin, such as paralysis or stress on the skin, the body positions need to minimize the risk of pressure on vulnerable areas.Based on this information, no further action is required.

• Brand Name: ECLIPSE ASSEMBLY
• Type of Device: BED FLOTATION THERAPY POWERED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state route 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3843778
• MDR Text Key: 4408477
• Report Number: 1824206-2014-01651
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Type of Report: Initial
• Report Date: 04/29/2014

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?: Yes
• Device Operator: Other
• Device Model Number: 0800
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/29/2014
• Initial Date FDA Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/1996
• 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): Hospitalization
• Patient Age: 52 YR
• Patient Weight: 59