MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM HEATER-COOLER

Model Number	400CE
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Gentherm received a call ((b)(4)) stating the hemotherm devices would not reach set temperature for rewarming.The unit was replaced and rewarming was continued.The issue did not cause any patient harm but did result in delay of surgery.
Event or Problem Description
Customer reported on (b)(6) 2019 that on (b)(6) 2019 the hemotherm device would not go above 34c.A replacement unit was brought in and warming continued.Customer reported that there was no patient harm but there was a delay in surgery.

• Brand Name: HEMOTHERM HEATER-COOLER
• Common Device Name: HEMOTHERM HEATER-COOLER
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller; cincinnati OH 45241
• MDR Report Key: 9604709
• Report Number: 1516825-2020-00001
• Device Sequence Number: 2352971
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K122813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/17/2020

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: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1