MAUDE Adverse Event Report: CAS MEDICAL SYSTEMS, INC. FORE-SIGHT ELITE TISSUE OXIMETER SENSOR(S); CEREBRAL OXIMETER SENSOR

Model Number	SMALL AND NON ADHESIVE SMALL
Health Effect - Clinical Codes	Erythema (1840); Swelling (2091)
Date of Event	11/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user went off-label not checking the sensor site at the recommended intervals.From photo evidence it is apparent that two sizes of sensors were used together which is not a typical practice and one of those was used incorrectly by the ifu.Also, photo evidence shows the delivery of lasix indicating a treatment for edema, which the ifu cautions to be aware of so as not to over tighten the sensor holding headband and possibly creating an over pressure injury.
Event or Problem Description
A patient that had open heart surgery was recovering when, after 48 hours of cerebral oximetry monitoring, the sensor site was checked to find redness and swelling on the forehead and under the application site.

• Brand Name: FORE-SIGHT ELITE TISSUE OXIMETER SENSOR(S)
• Common Device Name: CEREBRAL OXIMETER SENSOR
• Manufacturer (Section D): CAS MEDICAL SYSTEMS, INC.; 44 east industrial road; branford CT 06475
• MDR Report Key: 7134101
• Report Number: 2244861-2017-00002
• Device Sequence Number: 10786507
• Product Code: MUD
• UDI-Device Identifier: 10609538711012
• UDI-Public: (01)10609538711012(10)201622(01)10609538711005(10)201641
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K143675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2017

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: Health Professional
• Device Model Number: SMALL AND NON ADHESIVE SMALL
• Device Catalogue Number: 01-07-1100, 01-07-1101
• Device Lot Number: 2016-22, 2016-41
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LASIX
• Outcome Attributed to Adverse Event: Other
• Patient Age: 1 MO
• Patient Weight: 3