MAUDE Adverse Event Report: O&M HALYARD, INC. PATIENT WARMING SYSTEM M1000 CONTROL UNIT; TEMPERATURE MANAGEMENT PRODUCTS

Model Number 01000-01

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 03/18/2022

Event Type  Injury  

Event Description

Patient 2 of 2.A fda medwatch report (b)(4) was received 04aug2022.The report states that there were two patients that had second degree burns to their backs which increased their hospital stay.This hospital was using a kimberly-clark intraoperative warming system m1000 (made by o&m halyard, inc.) during cardiac surgery starting (b)(6) 2022.The gel pads are applied to the back with a warming console that has water.A joint patient safety report was done on both cases.One patient required wound care service.

Manufacturer Narrative

The product involved in the event was not available for return.A follow-up report will be provided upon conclusion of investigation.All information reasonably known as of 31aug2022 has been included in this medical device report.The information provided by o&m halyard, inc.Represents all of the known information at this time.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.Device not returned.

Manufacturer Narrative

The device was sent to nortech (the device servicer) where calibration, functional, and safety tests were performed.The devices passed all tests and nortech was not able to duplicate the customer experience.We will continue to monitor the field performance of this product.All information reasonably known as of (b)(6) 2023 has been included in this medical device report.The information provided by(b)(6).Represents all of the known information at this time.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to (b)(4), in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.

• Brand Name: PATIENT WARMING SYSTEM M1000 CONTROL UNIT
• Type of Device: TEMPERATURE MANAGEMENT PRODUCTS
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): NORTECH SYSTEMS, INC.; 925 6th avenue ne; milaca MN 56353
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 15329079
• MDR Text Key: 299088775
• Report Number: 3014421917-2022-00002
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01000-01
• Device Catalogue Number: 991094765
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 78 KG