MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHERM 400CE; HEATER COOLER DEVICE

Model Number 400CE

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2020

Event Type  malfunction  

Manufacturer Narrative

Customer reported the hemohterm 400ce identified error code ee 02 (heat thermistor discrepancy - replace thermistor).Error was corrected.No patient/user injury reported.

Event Description

During a surgery, the hemotherm 400ce sent the ee02 error message indicating a heat thermistor discrepancy - replace thermistor.No patient/user injury was reported.

• Brand Name: HEMOTHERM 400CE
• Type of Device: HEATER COOLER DEVICE
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller; cincinnati, oh
• Manufacturer (Section G): GENTHERM MEDICAL, LLC; 12011 mosteller; cincinnati, oh
• Manufacturer Contact: christina miracle ; 12011 mosteller; cincinnati, oh ; 6125295
• MDR Report Key: 9915397
• MDR Text Key: 202551370
• Report Number: 1516825-2020-00003
• 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: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• 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: 86023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1