FDA Adverse Event
Malfunction
Summary report: N
RD RAINBOW LITE SET-1 NEO ADH
MDR report key: 24285006
·
Received February 6, 2026
Report
- Report Number
- 3019388613-2026-00038
- Event Type
- Malfunction
- Date Received
- February 6, 2026
- Date of Event
- January 11, 2026
- Report Date
- January 12, 2026
- Manufacturer
- MASIMO - 15750 ALTON PKWY
- Product Code
- QWE
- UDI-DI
- 10843997011751
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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 · 0
THE CUSTOMER REPORTED THE SENSOR "STOPPED EMITTING LIGHT MIDWAY." THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3030 | RD RAINBOW LITE SET-1 NEO ADH | HYPEROXIA MONITORING DEVICE ADJUNCT TO PULSE OXIMETRY | QWE | MASIMO - 15750 ALTON PKWY | 4045 | 24J52 | 10843997011751 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |