MAUDE Adverse Event Report: HILL-ROM, INC. SYNERGY AIR ELITE BLOWER; BED, FLOTATION THERAPY, POWERED

Model Number 6881CAP

Device Problems Inflation Problem (1310); Improper or Incorrect Procedure or Method (2017)

Patient Problems Pressure Sores (2326); Injury (2348)

Event Date 02/24/2014

Event Type  Other  

Event Description

The caregiver reported the mattress is not inflating properly in the seat section and has caused three new pressure ulcers on the pt.The mattress is located in the pt's home.This report was filed in our complaint handling system as complaint # (b)(4).The hill-rom representative spoke with the caregiver to discuss the allegation of three new sores developing.The caregiver stated that the pt developed three new stage 3 sores over the weekend due to the mattress not inflating.The pt was receiving treatment for these wounds and they are healing nicely.The hill-rom representative asked the caregiver about having the mattress on top of another mattress and she could not confirm.There have been no new sores since the repair.The reported injury is serious in nature per fda definition.The cause of the malfunction is related to misuse.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 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.

Manufacturer Narrative

The hill-rom technician performed the investigation and per the caregiver, the mattress was not inflating properly in the seat section causing the pt multiple pressure ulcers.Pt was given wound dressings.The caregiver would not release any other information.The hill-rom technician inspected the mattress and found the account had placed this hill-rom mattress over another mattress.The synergy air elite is a mattress replacement, not an overlay and this caused three seat section bladders in the mattress to partially disconnect and the shear protector to be pulled to one side.The technician corrected the issue by reinstalling the bladders and shear protector.The technician also replaced a clogged air filter as a preventative maintenance measure.The mattress is now installed correctly on the bed and is functioning as designed.

• Brand Name: SYNERGY AIR ELITE BLOWER
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM, INC.; charleston SC
• Manufacturer Contact: jennifer morris ; 1069 state route 46 east; batesville, IN 47006 ; 8129313121
• MDR Report Key: 3716541
• MDR Text Key: 4336682
• Report Number: 1045510-2014-00001
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/24/2014

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: Health Professional
• Device Model Number: 6881CAP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2014
• Initial Date FDA Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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: 53 YR
• Patient Weight: 76