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

Model Number 400CE

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The customer stated that this hemotherm unit failed, the temperature would not go above 36°c.The unit was swapped out.No adverse event reported.(b)(4).

Event Description

The customer stated that the hemotherm unit failed, the temperature would not go above 36°c.The unit was swapped out.No adverse event reported.

• Brand Name: HEMOTHERM
• Type of Device: HEATER/COOLER
• Manufacturer (Section D): GENTHERM MEDICAL; 12011 mosteller road; cincinnati, oh
• Manufacturer (Section G): GENTHERM MEDICAL; 12011 mosteller road; cincinnati, oh
• Manufacturer Contact: christina miracle ; 12011 mosteller road; cincinnati, oh ; 3265295
• MDR Report Key: 10162989
• MDR Text Key: 196076895
• Report Number: 1516825-2020-00007
• 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: user facility
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• 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: 96022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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