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

Model Number U101

Device Problems Charred (1086); Intermittent Continuity (1121); Electrical /Electronic Property Problem (1198); Naturally Worn (2988); Device Handling Problem (3265)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

Hospital has rejected requests for device return and event-related patient information.Hospital requested stop contact until they conclude their evaluation and reach out to the distributor or company.

Event Description

Hospital notified (b)(6) distributor of an incident: "a patient had received burns to skin and we suspect they have come from a hot dog underwarming blanket." hospital later confirmed device serial number as (b)(4), which was determined to be a u101 under body mattress, not blanket as reported.

Manufacturer Narrative

Controllers (2) returned for performance evaluation were observed to perform according to established functional and safety performance test requirements - no issues were found.U101 sn (b)(4) was evaluated and observed in aged condition (> 30 months of field use) and damaged via use.Sewing construction and appearance of the conductive thread appeared normal and without thermal degradation.Ir image of the mattress function - clearly indicated a non-performing mattress and the test controller provided designed alarm e2 alarm, consistent with hospital reporting of multiple e2 alarms through the use of two controllers, which provided audible and visual user alarms that this mattress would not not reach set-point temperature within the design time limit.Conclusion: hospital misue of allowing continued multiple controller alarm resets outside of the defined parameter/instructions established per the ifu.In addition, the hospital was advised by an authorized account representative in early 2017 that their products were beyond the currently established 30-month expiry (implemented july 1, 2015), did not furnish all warming product devices for testing/confirmation of performance, and did not replace old units as recommeded, and continued to used existing/old inventory.Since mattress introduction into worldwide distribution, this is the second reported event (device incidence rate of 0.08%), and the first event related to a thermal injury (second degree burn/blistering) which was medically deemed treatable and non-life threatening by hospital personnel.Being a reusable device, hot dog mattresses have been used in an estimated (b)(4) surgeries since introduction.Thjs represents an injury rate of ~ (b)(4) % or about (b)(4) uses.Had the hospital adhered to recommendations of authorized account representatives in early 2017, and followed ifu requirements, this incident would have been avoided.

• Brand Name: HOT DOG PATIENT WARMING UNDER BODY MATTRESS
• Type of Device: U101 SMALL UNDER BODY WARMING MATTRESS
• Manufacturer (Section D): AUGUSTINE BIOMEDICAL & DESIGN, LLC; 6581 city west parkway; eden prairie MN 55344
• Manufacturer (Section G): AUGUSTINE TEMPERATURE MANAGEMENT LLC; 7656 w. 78th st.; minneapolis MN 55439
• Manufacturer Contact: jasper blake ; 6581 city west parkway; eden prairie, MN 55344 ; 9524653512
• MDR Report Key: 6933483
• MDR Text Key: 88701891
• Report Number: 3005857264-2017-00003
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 11/06/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2014
• 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
• Patient Outcome(s): Other