ENSOETM ECD04-A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-09-11 for ENSOETM ECD04-A manufactured by Advanced Cooling Therapy Inc. D/b/a Attune Medical.

MAUDE Entry Details

• Report Number: 3010412492-2019-00001
• MDR Report Key: 8995055
• Report Source: USER FACILITY
• Date Received: 2019-09-11
• Date of Report: 2019-09-13
• Date of Event: 2019-08-12
• Date Mfgr Received: 2019-08-15
• Device Manufacturer Date: 2019-03-12
• Date Added to Maude: 2019-09-11
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: DR. ERIK KULSTAD
• Manufacturer Street: 3440 S DEARBORN ST #215-SOUTH
• Manufacturer City: CHICAGO IL 60616
• Manufacturer Country: US
• Manufacturer Postal: 60616
• Manufacturer Phone: 8885344873
• Manufacturer G1: ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL
• Manufacturer Street: 3440 S DEARBORN ST #215-SOUTH
• Manufacturer City: CHICAGO IL 60616
• Manufacturer Country: US
• Manufacturer Postal Code: 60616
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ENSOETM
• Generic Name: ESOPHAGEAL THERMAL REGULATION DEVICE
• Product Code: PLA
• Date Received: 2019-09-11
• Model Number: ECD04-A
• Lot Number: 199207119
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ADVANCED COOLING THERAPY INC. D/B/A ATTUNE MEDICAL
• Manufacturer Address: 3440 S DEARBORN ST #215-SOUTH CHICAGO IL 60616 US 60616

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2019-09-11