NELLCOR PULSE OXIMETER PROBE
Received May 16, 2026 · Event occurred Apr 11, 2026
Report 3032391-2026-00009 · MDR key 25194829
Device
Product problems
- Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT, UNIT SUGGESTED SEVERAL OCCURRENCES WITH REPROCESSED PULSE OXIMETERS WITH FAULTY ACCURACY LEADING TO DELAYS INPATIENT CARE. ALSO, SUGGESTED DIFFERENCES IN READINGS ON PORTABLE VS. BEDSIDE MONITOR. DUE TO UNCERTAINTY OF THE PERFORMANCE OF THE DEVICE, ADDITIONAL PROCEDURES WERE TAKEN TO ENSURE SAFETY OF THE PATIENT. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT, UNIT SUGGESTED SEVERAL OCCURRENCES WITH REPROCESSED PULSE OXIMETERS WITH FAULTY ACCURACY LEADING TO DELAYS INPATIENT CARE. ALSO, SUGGESTED DIFFERENCES IN READINGS ON PORTABLE VS. BEDSIDE MONITOR. DUE TO UNCERTAINTY OF THE PERFORMANCE OF THE DEVICE, ADDITIONAL PROCEDURES WERE TAKEN TO ENSURE SAFETY OF THE PATIENT.