MAUDE Adverse Event Report: CIRCA SCIENTIFIC, LLC S-CATH; THERMOMETER, ELECTRONIC, CLINICAL

Catalog Number CS-2001

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2019

Event Type  malfunction  

Event Description

Circa temperature probe (esophageal temperature probe) was placed by anesthesia but it wouldn't show poles 5&6 message noting inoperable.It was replaced with a new one and worked fine (same lot number).The patient was not affected.

• Brand Name: S-CATH
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): CIRCA SCIENTIFIC, LLC; 14 iverness dr east; ste h-136; englewood CO 80112
• MDR Report Key: 8835787
• MDR Text Key: 152488858
• Report Number: 8835787
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2019,06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: CS-2001
• Device Lot Number: 13588-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1