MAUDE Adverse Event Report: FORESIGHT ELITE OXIMETER; FSEO2004

Model Number	FSEO2004
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not been returned for evaluation.When it arrives and the product evaluation has been completed a supplemental report will be submitted.The device history record review was unable to be located during this complaint investigation, the most likely cause of this is the records were destroyed based on casmeds document retention period for dhrs.
Event or Problem Description
It was reported that the fseo2004 started giving numbers that are outside the simulator calibrated range.When the simulator is connected the readings should be within 10 percent of 65.The readings are either high or low and thus not calibrated.This was before use.There is no patient injury.Patient demographics were requested but unavailable.
Additional Manufacturer Narrative
One foresight elite oximeter was received for product evaluation.A visual inspection did not find any visible physical damage.The suspect unit was connected to a known good working system.Using simulators, the sto2 readings of all 4 channels showed 65 percent plus or minus 5 percent and remained steady even while moving the cables.No error messages were observed.There was no defect found.

• Brand Name: FORESIGHT ELITE OXIMETER
• Common Device Name: FSEO2004
• MDR Report Key: 12468929
• Report Number: 2015691-2021-05172
• Device Sequence Number: 3821227
• Product Code: DXO
• UDI-Device Identifier: 00690103208597
• UDI-Public: (01)00690103208597(11)200318
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K142749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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
• Operator of Device: Health Professional
• Device Model Number: FSEO2004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1