Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FORESIGHT ELITE OXIMETER; FSEO2004
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FORESIGHT ELITE OXIMETER; FSEO2004 Back to Search Results
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 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.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
After several attempts made to request product return from the customer, there was no response received.The product was not returned for evaluation.If the product does arrive, a supplemental report will be submitted with the evaluation findings.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FORESIGHT ELITE OXIMETER
Type of Device
FSEO2004
MDR Report Key12468799
MDR Text Key271319005
Report Number2015691-2021-05170
Device Sequence Number1
Product Code DXO
Combination Product (y/n)N
PMA/PMN Number
K142749
Number of Events Reported1
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 Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFSEO2004
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-