NELLCOR PULSE OXIMETER
Received Jun 11, 2026 · Event occurred May 5, 2026
Report 3032391-2026-00032 · MDR key 25480798
Device
Product problems
- Material Deformation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT TWO MORE CLINICS RECEIVED DAMAGED SENSORS. UPON RECEIVING SHIPMENT, SENSORS WERE CHECKED OVER AND SET ASIDE WHEN A 9-PIN CONNECTOR WOULD NOT ATTACH TO VITALS CART DUE TO MALFORMATION. 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 IS A REPORTABLE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.
Description of Event or Problem
IT WAS REPORTED THAT, TWO MORE CLINICS RECEIVED DAMAGED SENSORS. UPON RECEIVING SHIPMENT, SENSORS WERE CHECKED OVER AND SET ASIDE WHEN A 9-PIN CONNECTOR WOULD NOT ATTACH TO VITALS CART DUE TO MALFORMATION.