MalfunctionOLV
EMBLETTA MPR PG
Received Aug 8, 2023 · Event occurred Jul 5, 2023
Report 17479681 · MDR key 17479681
Device
Generic name
Standard Polysomnograph With Electroencephalograph
Manufacturer
Natus Medical IncorporatedPatient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE PULSE OXIMETER DURING PATIENT'S HOME SLEEP STUDY FAILED TO TURN ON FOR THE PATIENT AT HOME. PATIENT DID WEAR THE HOME SLEEP TEST ANYWAY, BUT BECAUSE THERE WAS NO OXIMETRY READING THE PATIENT HAD TO REPEAT THE TEST. AFTER SPEAKING WITH THE DIRECTOR OF SLEEP CENTER, SHE REPORTED THIS IS THE 3RD OXIMETER, OF THIS TYPE, THAT HAS FAILED TO TURN ON DURING A STUDY.