MAUDE Adverse Event Report: FORESIGHT ELITE OXIMETER; FSEO2004

Model Number FSEO2004

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  malfunction  

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 not completed but will be provided after it has been finished.The udi number is not available.

Event 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.

Manufacturer Narrative

One foresight elite oximeter was received for product evaluation.A visual inspection found that both of the sensor cables strain reliefs on the module ends are damaged.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.

• Brand Name: FORESIGHT ELITE OXIMETER
• Type of Device: FSEO2004
• MDR Report Key: 12468849
• MDR Text Key: 271314726
• Report Number: 2015691-2021-05171
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• PMA/PMN Number: K142749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1