MAUDE Adverse Event Report: GENTHERM MEDICAL, LLC HEMOTHER HEATER COOLER

Model Number 400CE

Device Problem Output Problem (3005)

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

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

A customer report was received on (b)(6) 2019 (cdr # (b)(4)) stating the heomtherm heater-cooler alarmed with an ee03 code.It was determined the thermistor required replacement.

Event Description

A customer reported the hemotherm 400ce went down during a case with an ee03 error.No patient injury was reported.

• Brand Name: HEMOTHER HEATER COOLER
• Type of Device: HEATER COOLER
• Manufacturer (Section D): GENTHERM MEDICAL, LLC; 12011 mosteller; cincinnati OH 45241
• Manufacturer (Section G): GENTHERM MEDICAL, LLC; 12011 mosteller; cincinnati OH 45241
• Manufacturer Contact: christina miracle ; 12011 mosteller; cincinnati, OH 45241 ; 8009897373
• MDR Report Key: 8983417
• MDR Text Key: 204456890
• Report Number: 1516825-2019-00012
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• 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: 86022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2017
• 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