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

Model Number 0800

Device Problems Lack of Maintenance Documentation or Guidelines (2971); Material Protrusion/Extrusion (2979)

Patient Problems Pressure Sores (2326); Discomfort (2330)

Event Date 02/09/2014

Event Type  Other  

Event Description

The consumer reported the pt was lying on a hard tube and developing a bed sore.The bed was located in the pt's home.(b)(4).A search of the hill-rom maintenance records did not show hill-rom performed an preventative maintenance on this bed.It is unk if the consumer performs preventative maintenance on the bed.The hill-rom representative spoke with the caregiver to ask about the allegation of a new bed sore developing on his mother's back.The caregiver stated that his mother does have preexisting sores and that because of a tube sticking out she developed one new sore.She currently is having treatment weekly for her preexisting sores and sought new medical treatment for the new sore.The caregiver stated that he thought it was a stage 3 sore that developed.The hill-rom representative asked if his mother was ever removed from the bed when she noticed the discomfort, and the caregiver stated no.The caregiver stated the pt has had no issue since being transferred to the new bed.The reported injury is serious in nature per fda definition; however, there was no evidence of a malfunction.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.No repair was needed the bed functioned as designed but was swapped for a known working bed for insurance proposed.Based on this info, no further action is required.

Manufacturer Narrative

The technician reported the mattress tubing was sticking the patient.The technician found the bead wall was out of adjustment and swapped the bed for a known working bed.The hill-rom representative spoke with the technician that state the consumer brought to his attention during the repair that the pt was getting bed sores but the technician found no malfunction with the bed.Per the technician the tube that connects to the bead wall was not out of adjustment and that the pt was positioned incorrectly and was up against the bead wall.There was no issue found with bead wall and that the unit was swapped only because of insurance purposes and when he took the bed back to the warehouse and inspected it that is when he found holes in the bead wall.

• Brand Name: CLINITRON AT HOME
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: jennifer morris ; 1069 state route 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3683315
• MDR Text Key: 20104017
• Report Number: 1824206-2014-00775
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• PMA/PMN Number: K942184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Type of Report: Initial
• Report Date: 02/09/2014

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
• Initial Date Manufacturer Received: 02/09/2014
• Initial Date FDA Received: 03/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2007
• 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