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

Model Number 400CE

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2019

Event Type  malfunction  

Manufacturer Narrative

Gentherm received an allegation (b)(4) of a hemotherm that, during a procedure, the heater/cooler was being set to cool and made a popping noise followed by an electrical burn smell.The unit was replaced and the procedure finished with no patient harm.The unit has not been returned for evaluation.

Event Description

During a procedure, the hemotherm heater/cooler was being set to cool and made a popping noise followed by an electrical burn smell.The unit was replaced and the procedure finished with no patient harm.

• Brand Name: HEMOTHERM HEATER-COOLER
• Type of Device: HEATER-COOLER
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller; cincinnati OH 45241
• Manufacturer (Section G): GENTHERM MEDICAL, LLC; 12011 mosteller; cincinnati OH 45241
• Manufacturer Contact: christina miracle ; 12011 mosteller; cincinnati, OH 45241 ; 5133265295
• MDR Report Key: 9506503
• MDR Text Key: 172310865
• Report Number: 1516825-2019-00015
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1