HEMOSPHERE ALTA
Received Jun 17, 2026 · Event occurred May 27, 2026
Report 2015691-2026-16094 · MDR key 25533636
Device
Generic name
Catheter, Oximeter, Fiber-optic
Manufacturer
Edwards LifesciencesModel number
ALTASR1Lot number
19Y0003495
Product problems
- Incorrect Measurement
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING USE THE HEMOSPHERE ALTA SMARY RECOVERY SYSTEM APPEARED TO BE FUNCTIONING INCORRECTLY, SHOWING INACCURATE READINGS. TROUBLESHOOTING MEASURES WERE ATTEMPTED; HOWEVER, THE ISSUE PERSISTED, AND THE SYSTEM CONTINUED TO PRODUCE INACCURATE READINGS. THERE WAS NO ALLEGATION OF PATIENT HARM REPORTED.
Additional Manufacturer Narrative
THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW. D2B. ADDITIONAL DEVICE PRODUCT CODE: DSB, DXN, FLL, MUD, QAQ, QEM, QMS, QNL, DQK. G4 ADDITIONAL 510K CODE: K242451.