MalfunctionQWE
RD RAINBOW LITE SET-1 NEO ADH
Received Feb 6, 2026 · Event occurred Jan 11, 2026
Report 3019388613-2026-00038 · MDR key 24285006
Device
Generic name
Hyperoxia Monitoring Device Adjunct To Pulse Oximetry
Manufacturer
Masimo - 15750 Alton PkwyModel number
4045Lot number
24J52
Product problems
- Sensing Intermittently
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
OTHER TEXT: DEVICE EVALUATION IS ANTICIPATED. AT THE CONCLUSION OF OUR INVESTIGATION OR IF 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 ALLOWABLE FIELD LENGTH, INITIAL REPORTER ZIP CODE IS AS FOLLOWS: (B)(6).
Description of Event or Problem
THE CUSTOMER REPORTED THE SENSOR "STOPPED EMITTING LIGHT MIDWAY." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Remedial action
- Other