RD SET™ NK-12 RD SET Series Patient Cable 4192Recalls & reported problems
Masimo Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843997010726), received between Feb 10, 2017 and Jan 27, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Incorrect Measurement2
- Sensing Intermittently1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2020Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED INTERMITTENT SPO2 READINGS WITH THE RD CABLE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9634943 ↗MalfunctionMar 22, 2017Incorrect Measurement; Incorrect Measurement
CUSTOMER REPORTED "LOW SPO2 VALUES WITH RD NIHON KOHDEN CABLES AND CABLES EASILY DISCONNECTED FROM SENSOR". NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6424196 ↗MalfunctionFeb 10, 2017Incorrect Measurement; Incorrect Measurement
CUSTOMER REPORTED "LOW SPO2 VALUES WITH RD NIHON KOHDEN CABLES AND CABLES EASILY DISCONNECTED FROM SENSOR". NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6324469 ↗
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- HAMILTON-G5 159002Hamilton Medical AG · Oximeter3 deaths451 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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