RD SET™ SL-12 RD SET to SpaceLabs Patient Cable 4087Recalls & 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 00843997010559), received between May 4, 2017 and Dec 29, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device Operates Differently Than Expected1
- Device Stops Intermittently1
- High Readings1
- Sensing Intermittently1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2023High Readings; High Readings
THE CUSTOMER REPORTED THE SPO2 PROBE WAS READING ERRONEOUSLY HIGH AS VERIFIED BY ARTERIAL BLOOD GAS. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18418543 ↗MalfunctionJul 28, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE CABLE EITHER STARTS AND THEN STOPS WORKING OR WILL NOT WORK AT ALL. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12241549 ↗MalfunctionMay 4, 2017Device Stops Intermittently; Device Operates Differently Than Expected; Device Stops Intermittently; Device Operates Differently Than Expected
IT WAS REPORTED THAT "CUSTOMER WIGGLED THE CABLE NEAREST THE SPACELAB CONNECTION, THE PROBE STOPS READING". NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 6546369 ↗
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- HAMILTON-G5 159001Hamilton Medical AG · Oximeter18 deaths1,440 reports
- Trilogy Trilogy100 Ventilator, GermanyRespironics, Inc. · Oximeter696 reports
- Model EMV+ Vent, Army, MRI 799-EMVP-04Zoll Medical Corporation · Oximeter1 death605 reports
- Trilogy Evo, O2, Japan JP2100X16BRespironics, Inc. · Oximeter4 recalls5 deaths342 reports
- Model EMV+ Vent, Army, COMMERCIAL 799-EMVP-01-01Zoll Medical Corporation · Oximeter1 death497 reports
- 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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