O3 SENSOR
Received Jun 5, 2026 · Event occurred May 10, 2026
Report 3019388613-2026-00284 · MDR key 25408541
Device
Generic name
Oximeter, Tissue Saturation
Manufacturer
Masimo - 15750 Alton PkwyModel number
3756Lot number
23CCC
Product problems
- Low Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE MEASURED VALUE IS INCORRECT. IT SHOWS ABNORMALLY LOW VALUES. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Additional Manufacturer Narrative
OTHER, OTHER TEXT: THE DEVICE HAS NOT BEEN RETURNED TO THE INVESTIGATION FACILITY TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF THE DEVICE IS RECEIVED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. HEALTH EFFECT IMPACT CODE: NO ADVERSE EVENT; NO PATIENT IMPACT. E1. INITIAL REPORTER ZIP CODE EXCEEDED THE MAXIMUM ALLOWABLE CHARACTERS, ZIP CODE IS AS FOLLOWS: (B)(6).
Remedial action
- Other