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

Model Number 400CE

Device Problems Break (1069); Failure to Pump (1502)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

Customer called in from the or with the hemotherm 400ce not pumping water.The customer was walked through evaluating the fuses on the power supply board.During the evaluation, it was discovered the device had a blown 20a fuse.The customer was able to replace the fuse to correct the malfunction and continue with the case without further incident.No adverse event reported.

Event Description

Customer called in from the or with the hemotherm 400ce not pumping water.The customer was walked through evaluating the fuses on the power supply board.During the evaluation, it was discovered the device had a blown 20a fuse.The customer was able to replace the fuse to correct the malfunction and continue with the case without further incident.No adverse event reported.

• Brand Name: HEMOTHERM
• Type of Device: HEATER/COOLER
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller road; cincinnati OH 45241
• Manufacturer (Section G): GENTHERM MEDICAL, LLC; 12011 mosteller road; cincinnati OH 45241
• Manufacturer Contact: jodi fischesser ; 12011 mosteller road; cincinnati, OH 45241 ; 5133265237
• MDR Report Key: 11049686
• MDR Text Key: 223401860
• Report Number: 1516825-2020-00011
• Device Sequence Number: 1
• Product Code: DWC
• UDI-Device Identifier: 10613031860221
• UDI-Public: (01)10613031860221
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K122813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2017
• 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