MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM

Model Number 400CE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Alteration in Body Temperature (4568)

Event Date 05/23/2022

Event Type  malfunction  

Manufacturer Narrative

Fda report, mw5110281, received by gentherm medical, llc on 6/23/2022.The customer wishes to remain anonymous.Gentherm is unable to attempt to retrieve this device for evaluation as a result.

Event Description

While patient was in open heart surgery his temperature could not be maintained and it was discovered that the hemotherm machine was not functioning/not heating.It was discovered that the machine had a faulty heating element.

• Brand Name: HEMOTHERM
• Type of Device: HEMOTHERM
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• Manufacturer (Section G): GENTHERM MEDICAL, LLC; 12011 mosteller rd; cincinnati OH 45241
• Manufacturer Contact: angie gegner ; 12011 mosteller rd; cincinnati, OH 45241
• MDR Report Key: 15077911
• MDR Text Key: 296350699
• Report Number: 1516825-2022-00004
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K122813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2022

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
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1