MAUDE Adverse Event Report: FREEDOM MEDICAL, INC. FREEDOM MEDICAL WAVE MATTRESS WITH SMARTWAVE TECHNOLOGY; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problems Inflation Problem (1310); Device Inoperable (1663)

Patient Problem Pressure Sores (2326)

Event Date 03/21/2018

Event Type  malfunction  

Event Description

Patient was on a bariatric freedom wave mattress that stayed over inflated.It was thought to be a problem with the pump.We have had several at least 7 other events about patients with pressure ulcers.These events all involved a malfunctioning freedom wave mattress, but at the time no one related the issue to possibly being the malfunctioning freedom wave mattress.Manufacturer response for freedom medical wave mattress with smart wave technology, freedom medical wave mattress with smartwave technology (per site reporter).The manufacturer representative came in to look at the malfunctioning bed/mattress system and replaced all the motors but this did not seem to resolve the problem.At this time, the decision has been made to no longer use this mattress system.

• Brand Name: FREEDOM MEDICAL WAVE MATTRESS WITH SMARTWAVE TECHNOLOGY
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): FREEDOM MEDICAL, INC.; 219 welsh pool rd.; exton PA 19341
• MDR Report Key: 7453674
• MDR Text Key: 106302591
• Report Number: 7453674
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1