MAUDE Adverse Event Report: FLUID IMMERSION MATTRESS PLATINUM 6000; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Catalog Number ORDER # C466231

Device Problem Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Date 04/02/2022

Event Type  malfunction  

Event Description

Fluid immersion mattress unit would not turn on.Sizewise, now agilili.Fda safety report id# (b)(4).

• Brand Name: FLUID IMMERSION MATTRESS PLATINUM 6000
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• MDR Report Key: 14416937
• MDR Text Key: 291981582
• Report Number: MW5109753
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ORDER # C466231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2022
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male