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

Model Number ECD01-A

Device Problem Temperature Problem (3022)

Patient Problem Alteration In Body Temperature (2682)

Event Date 04/20/2019

Event Type  malfunction  

Event 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 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
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): GAYMAR INDUSTRIES, INC.; 3440 s. dearborn st.; #215-s; chicago IL 60616
• MDR Report Key: 8603274
• MDR Text Key: 144865170
• Report Number: 8603274
• Device Sequence Number: 1
• Product Code: PLA
• UDI-Device Identifier: 00857915006043
• UDI-Public: (01)00857915006043
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ECD01-A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13870 DA
• Patient Weight: 105