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

Model Number 400CE

Device Problems Defective Device (2588); Infusion or Flow Problem (2964)

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

Event Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

Customer reported the unit started draining during a procedure.No injury reported.Device received and evaluated: debris was found in heat outlet solenoid and the power cord was altered.Both issues were corrected.

Event Description

Customer reported issue: during a procedure while in heating mode the heat reservoir began to empty.

• Brand Name: HEMOTHERM
• 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
• MDR Report Key: 9924829
• MDR Text Key: 202554470
• Report Number: 1516825-2020-00004
• 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: Repair
• Type of Report: Initial
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• 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: 86022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2019
• 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