MAUDE Adverse Event Report: AUGUSTINE BIOMEDICAL & DESIGN, LLC HOT DOG PATIENT WARMING SYSTEM; U101 SMALL UNDERBODY WARMING MATTRESS

Model Number U101

Device Problems Thermal Decomposition of Device (1071); Intermittent Continuity (1121); Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2017

Event Type  malfunction  

Manufacturer Narrative

Visual and electrical analysis of the returned device suggest the most likely cause of this failure is heater fabric resistance change due to aging.This mattress has been in use for over 60 months, well beyond the 30 month expected life of the device, which increases the chances of mechanical and/or electrical damage.With age, electrical resistance of the heater fabric increases and electrical continuity may be impaired resulting in damage.The electrical resistance of the heater fabric of the returned device was 3 - 4 times that of nominal at time manufacture and consistent with age.With sufficient aging, the device will fail to reach set-point temperature within 10 minutes, and initiate an alarm by the controller.Although not qualified, we believe this alarm condition is consistent with user report.Due to aging, and electrical continuity issues, this mattress was unable to heat because of the damage to the heater fabric.Ir thermal imaging shows almost no heating with only few small warm spots (measuring below 29 deg.C) in the area of buss/heater fabric failure.The conductive thread that connects the buss to heater fabric did not exhibit signs of corrosion or degradation, and there was no mechanical damage to the heater fabric outside the charred areas.It is unclear if this mattress caused similar alarms before this incident.However, the measured resistance of the heater fabric suggests that this mattress would have likely caused an alarm before this reported incident as the extent of the damage exhibited could not have occurred within a single 10 minute window of heating.This is the first mattress heater failure of this kind since product introduction in 2010.

Event Description

As reported by the (b)(6)'s hospital via distributor: on (b)(6) 2017, the technical department of (b)(6) hospital, reported a mattress malfunction: during device use, there was a controller alarm (alarm code not noted) and mattress was disconnected for the remaining or procedure.Before following surgery staff checked the mattress and found a burn hole at the surface.The involved patient was not harmed physically.The staff decided to take the mattress out of order and to report the malfunction.

• Brand Name: HOT DOG PATIENT WARMING SYSTEM
• Type of Device: U101 SMALL UNDERBODY WARMING MATTRESS
• Manufacturer (Section D): AUGUSTINE BIOMEDICAL & DESIGN, LLC; 6581 city west parkway; eden prairie MN 55344
• Manufacturer (Section G): AUGUSTINE BIOMEDICAL & DESIGN, LLC; 7656 w. 78th st.; minneapolis MN 55439
• Manufacturer Contact: jasper blake ; 6581 city west parkway; eden prairie, MN 55344 ; 9524653512
• MDR Report Key: 6603765
• MDR Text Key: 76421244
• Report Number: 3005857264-2017-00002
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K112488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: U101
• Device Catalogue Number: U101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: HOT DOG CONTROLLER
• Patient Outcome(s): Other