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

Model Number 400CE

Device Problem Insufficient Heating (1287)

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

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported a heating malfunction occurred, the device stopped heating near the end of a surgical case.The device was set at 38 degrees, reached set temp at start of case but then dropped and would not rise to set point.The customer could not get the device to heat above 30 degrees even though the high and low heating led indicators are on.No adverse event reported.

Event Description

The customer reported a heating malfunction occurred, the device stopped heating near the end of a surgical case.The device was set at 38 degrees, reached set temp at start of case but then dropped and would not rise to set point.The customer could not get the device to heat above 30 degrees even though the high and low heating led indicators were on.No adverse event reported.

• Brand Name: HEMOTHERM
• Type of Device: HEATER/COOLER
• Manufacturer (Section D): GENTHERM MEDICAL; 12011 mosteller road; cincinnati OH 45241
• Manufacturer (Section G): GENTHERM MEDICAL; 12011 mosteller road; cincinnati OH 45241
• Manufacturer Contact: jodi fischesser ; 12011 mosteller road; cincinnati, OH 45241 ; 5133265237
• MDR Report Key: 10905050
• MDR Text Key: 231258422
• Report Number: 1516825-2020-00010
• 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: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2019
• 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