RD SET
Report
- Report Number
- 3019388613-2025-00188
- Event Type
- Malfunction
- Date Received
- December 31, 2025
- Date of Event
- December 2, 2025
- Report Date
- December 5, 2025
- Manufacturer
- MASIMO - 15750 ALTON PKWY
- Product Code
- DQA
- UDI-DI
- 00843997014298
- PMA / PMN Number
- K180046
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
OTHER TEXT: THE RETURNED SENSOR WAS EVALUATED. THE SENSOR PASSED VISUAL INSPECTION AND CONTINUITY TESTING. THE SENSOR WAS ABLE TO OBTAIN ACCURATE READINGS CONTINUOUSLY DURING FUNCTIONAL TESTING. THE SENSOR WAS DETERMINED TO BE FUNCTIONING AS DESIGNED. HEALTH EFFECT IMPACT CODE: NO ADVERSE EVENT, NO PATIENT IMPACT.
OTHER, OTHER TEXT: BASED ON ADDITIONAL INFORMATION THE FOLLOWING FIELDS WERE CORRECTED: SECTION D. SUSPECT MEDICAL DEVICE, G. ALL MANUFACTURERS, AND H. DEVICE MANUFACTURERS ONLY: D1. BRAND NAME WAS LNCS-II RAINBOW; IS RD SET. D4. MODEL # WAS 4067; IS 4052. D4. LOT # WAS <BLANK>; IS (B)(6). D4. UNIQUE DEVICE IDENTIFIER (UDI) # WAS (B)(4). G4. PMA/510(K) # WAS K080238; IS K180046. H4. DEVICE MANUFACTURE DATE WAS <BLANK>; IS 11/24/2022 H3 OTHER TEXT: SENSOR NOT RETURNED.
OTHER, OTHER TEXT: THE DEVICE HAS NOT BEEN RETURNED TO THE INVESTIGATION FACILITY TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RECEIVED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. HEALTH EFFECT IMPACT CODE: NO ADVERSE EVENT, NO PATIENT IMPACT, H3 OTHER TEXT: SENSOR NOT RETURNED.
THE CUSTOMER REPORTED "THE SENSOR STOPPED WORKING WHEN THE PATIENT WAS CONNECTED, BUT THERE WAS NO BREAKAGE ON THE DEVICE. THIS TYPE OF SENSOR HAS A HIGHER IMPEDANCE, RESULTING IN A SATURATION READING APPROXIMATELY 8-10 POINTS LOWER THAN ARTERIAL BLOOD GAS ANALYSIS. THIS HAS BEEN REPORTED SEVERAL TIMES BY MY TEAM. THE PERFUSION SIGNAL IS ABOVE 1, INDICATING A GOOD SIGNAL AND WAVEFORM." "THE CLINICIANS OBSERVED A SIGNIFICANT DISCREPANCY BETWEEN THE BLOOD GAS MEASUREMENT AND THE SPO2 MEASUREMENT." THE SPO2 MEASUREMENT FROM THE SENSOR WAS 99% AND THE ABG SO2 MEASUREMENT WAS 83.7%. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
THE CUSTOMER REPORTED "THE SENSOR STOPPED WORKING WHEN THE PATIENT WAS CONNECTED, BUT THERE WAS NO BREAKAGE ON THE DEVICE. THIS TYPE OF SENSOR HAS A HIGHER IMPEDANCE, RESULTING IN A SATURATION READING APPROXIMATELY 8-10 POINTS LOWER THAN ARTERIAL BLOOD GAS ANALYSIS. THIS HAS BEEN REPORTED SEVERAL TIMES BY MY TEAM. THE PERFUSION SIGNAL IS ABOVE 1, INDICATING A GOOD SIGNAL AND WAVEFORM." "THE CLINICIANS OBSERVED A SIGNIFICANT DISCREPANCY BETWEEN THE BLOOD GAS MEASUREMENT AND THE SPO2 MEASUREMENT." THE SPO2 MEASUREMENT FROM THE SENSOR WAS 99% AND THE ABG SO2 MEASUREMENT WAS 83.7%. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
THE CUSTOMER REPORTED "THE SENSOR STOPPED WORKING WHEN THE PATIENT WAS CONNECTED, BUT THERE WAS NO BREAKAGE ON THE DEVICE. THIS TYPE OF SENSOR HAS A HIGHER IMPEDANCE, RESULTING IN A SATURATION READING APPROXIMATELY 8-10 POINTS LOWER THAN ARTERIAL BLOOD GAS ANALYSIS. THIS HAS BEEN REPORTED SEVERAL TIMES BY MY TEAM. THE PERFUSION SIGNAL IS ABOVE 1, INDICATING A GOOD SIGNAL AND WAVEFORM". "THE CLINICIANS OBSERVED A SIGNIFICANT DISCREPANCY BETWEEN THE BLOOD GAS MEASUREMENT AND THE SPO2 MEASUREMENT". THE SPO2 MEASUREMENT FROM THE SENSOR WAS 99% AND THE ABG SO2 MEASUREMENT WAS 90%. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2707350 | RD SET | OXIMETER | DQA | MASIMO - 15750 ALTON PKWY | 4052 | 22M5H | 00843997014298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female |