MAUDE Adverse Event Report: GAYMAR INDUSTRIES, INC. MEDI-THERM III; SYSTEM, THERMAL REGULATING

Model Number	ECD01-A
Health Effect - Clinical Code	Alteration In Body Temperature (2682)
Date of Event	04/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patient undergoing targeted temperature management using gaymar machine and wraps.During maintenance portion of protocol, machine noted to be heating water temperature and elevating patient's core temp beyond desired number.Rn evaluated equipment and lines with co-workers.No visible issues to be adjusted with equipment, unknown cause of malfunction.Ice packs applied and patient care equipment notified that we need a new gaymar machine.Nursing forced to utilize cooling blanket and ice packs to keep patient at goal temp while continuing to attempt troubleshooting on only gaymar device available.
Event or Problem Description
Patient undergoing targeted temperature management using gaymar machine and wraps.During maintenance portion of protocol, machine noted to be heating water temperature and elevating patient's core temp beyond desired number.Rn evaluated equipment and lines with co-workers.No visible issues to be adjusted with equipment, unknown cause of malfunction.Ice packs applied and patient care equipment notified that we need a new gaymar machine.Nursing forced to utilize cooling blanket and ice packs to keep patient at goal temp while continuing to attempt troubleshooting on only gaymar device available.

• Brand Name: MEDI-THERM III
• Common Device Name: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): GAYMAR INDUSTRIES, INC.; 3440 s. dearborn st.; #215-s; chicago IL 60616
• MDR Report Key: 8603274
• Report Number: 8603274
• Device Sequence Number: 11390657
• Product Code: PLA
• UDI-Device Identifier: 00857915006043
• UDI-Public: (01)00857915006043
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2019
• Report Date (Section F): 04/25/2019

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
• Operator of Device: Health Professional
• Device Model Number: ECD01-A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 105
• Date Report Sent to FDA: 04/25/2019