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

Model Number 400CE

Device Problem Defective Device (2588)

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

Event Date 07/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6) received a call (cdr 60692) stating the hemotherm devices would not reach set temperature for rewarming.The unit was replaced and rewarming was continued.The issue did not cause any patient harm but did result in delay of surgery.

Event Description

Customer reported on (b)(6) 2019 that on (b)(6) 2019 the hemotherm device would not go above 34c.A replacement unit was brought in and warming continued.Customer reported that there was no patient harm but there was a delay in surgery.

• Brand Name: HEMOTHERM 400CE HEATER-COOLER
• Type of Device: HEMOTHERM 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 ; 5133265295
• MDR Report Key: 9604710
• MDR Text Key: 200667639
• Report Number: 1516825-2020-00002
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2019
• 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