MAUDE Adverse Event Report: CAS MEDICAL SYSTEMS, INC. FORE-SIGHT ELITE SMALL ADHESIVE SENSOR; TISSUE OXIMETER

Model Number	01-07-2101
Health Effect - Clinical Code	Erythema (1840)
Date of Event	04/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A neonate patient was found with red marks on the forehead after a small sto2 sensor was removed for an application site check or sensor removal.The use of the sensor was not consistent with the user directions and may have been un-checked for an extended period of time.This was a minor incident and the clinicians, including a skin wound specialist, were not overly concerned about the outcome.There is no record of medical intervention and a series of photographs 2-3 days apart show improvement.

• Brand Name: FORE-SIGHT ELITE SMALL ADHESIVE SENSOR
• Common Device Name: TISSUE OXIMETER
• Manufacturer (Section D): CAS MEDICAL SYSTEMS, INC.; 44 east industrial road; branford CT 06405
• MDR Report Key: 6566258
• Report Number: 2244861-2017-00001
• Device Sequence Number: 11043558
• Product Code: MUD
• UDI-Device Identifier: 10609538711012
• UDI-Public: 10609538711012
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K143675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Nurse
• Device Model Number: 01-07-2101
• Device Catalogue Number: 01-07-2101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 7 DA