RD SET™ GE-12 RD SET to GE Patient Cable 4085Recalls & reported problems
Masimo Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00843997009805), received between Feb 17, 2017 and Aug 5, 2022 — classified as 18 malfunctions.
The most frequently reported specific device problem is “Sensing Intermittently” (12 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
- Sensing Intermittently12
- Incorrect Measurement4
- Device Operates Differently Than Expected2
- Device Stops Intermittently2
Patient problems
- No Consequences Or Impact To Patient15
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2022Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE SENSOR PROVIDED "INTERMITTENT DROPOUTS DURING OR CASES."NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15180000 ↗MalfunctionDec 9, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE READINGS DROP OUT. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12973223 ↗MalfunctionNov 6, 2020Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE CABLE WORKS INTERMITTENTLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10803147 ↗MalfunctionOct 7, 2020Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THEY ARE EXPERIENCING INTERMITTENT SPO2 DROPOUTS AND READINGS. NO PATIENT IMPACT OR CONSEQUENCES HAVE BEEN REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10644957 ↗MalfunctionOct 7, 2020Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THEY ARE EXPERIENCING INTERMITTENT SPO2 DROPOUTS AND READINGS. NO PATIENT IMPACT OR CONSEQUENCES HAVE BEEN REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10644904 ↗MalfunctionOct 7, 2020Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THEY ARE EXPERIENCING INTERMITTENT SPO2 DROPOUTS AND READINGS. NO PATIENT IMPACT OR CONSEQUENCES HAVE BEEN REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10644891 ↗MalfunctionOct 7, 2020Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THEY ARE EXPERIENCING INTERMITTENT SPO2 DROPOUTS AND READINGS. NO PATIENT IMPACT OR CONSEQUENCES HAVE BEEN REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10644854 ↗MalfunctionApr 1, 2020Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED INTERMITTENT SPO2 DROPOUTS WITH THE RD CABLE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9912260 ↗MalfunctionApr 10, 2018Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED SPO2 DROPOUTS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7420249 ↗MalfunctionApr 10, 2018Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED SPO2 DROPOUTS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7420214 ↗MalfunctionMar 27, 2018Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE CABLE FAILED WHEN A PATIENT WAS CONNECTED TO THE SENSOR. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7376444 ↗MalfunctionMar 27, 2018Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE CABLE FAILED WHEN A PATIENT WAS CONNECTED TO THE SENSOR. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7376441 ↗MalfunctionSep 3, 2017Device Stops Intermittently; Device Stops Intermittently
THE CUSTOMER REPORTED ON INTERMITTENT LOSS OF SIGNAL (SENSOR RULED OUT AS PROBLEM) INTERMITTENT SIGNAL LOSS THROUGHOUT CASE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6840668 ↗MalfunctionAug 31, 2017Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THERE WERE BROKEN RD GE CABLES AND QUESTIONABLE SPO2 VALUES. RETURNING 6 RD GE 4085 CABLES. EXPOSED WIRES AT THE SENSOR CONNECTION. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6833406 ↗MalfunctionAug 31, 2017Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THERE WERE BROKEN RD GE CABLES AND QUESTIONABLE SPO2 VALUES. RETURNING 6 RD GE 4085 CABLES. EXPOSED WIRES AT THE SENSOR CONNECTION. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6833405 ↗MalfunctionApr 22, 2017Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THERE WERE BROKEN RD GE CABLES AND QUESTIONABLE SPO2 VALUES. RETURNING 6 RD GE 4085 CABLES. EXPOSED WIRES AT THE SENSOR CONNECTION. NO CONSEQUENCES OR IMPACT TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6514090 ↗MalfunctionMar 17, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED THAT "CUSTOMER REPORTS THAT SPO2 DROPS OUT AND FLAT LINES WHEN PT. HR DROPS". NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6412954 ↗MalfunctionFeb 17, 2017Incorrect Measurement; Device Stops Intermittently; Device Operates Differently Than Expected; Incorrect Measurement; Device Stops Intermittently; Device Operates Differently Than Expected
THE CUSTOMER REPORTED AN INTERRUPTION OF PATIENT MONITORING AND AN EXTENDED PERIOD OF TIME BEFORE THE SPO2 BEGINS TO READ. PER THE CUSTOMER, WHEN IT DOES BEGIN TO READ, IT STARTS VERY LOW AND THEN TAKES AN EXTENDED TIME TO COME UP TO THE EXPECTED SPO2. THE SPO2 WILL THEN RANDOMLY DROP-OUT AGAIN WITH THE SAME BEHAVIOR AS START-UP. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6341919 ↗
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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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