RD SET™ MP-05 RD SET to IVM/MMS 4082Recalls & reported problems
Masimo Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00843997009775), received between Nov 10, 2017 and Feb 21, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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
- Device Operates Differently Than Expected3
- Unable to Obtain Readings3
- Sensing Intermittently1
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2020Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED INTERMITTENT OPERATION WITH THE RD CABLE. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9742298 ↗MalfunctionNov 10, 2017Unable to Obtain Readings; Device Operates Differently Than Expected; Unable to Obtain Readings; Device Operates Differently Than Expected
THE CUSTOMER REPORTED CABLES STOPPED WORKING. THE INFORMATION WAS NOT READING ON THE SCREEN. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7018408 ↗MalfunctionNov 10, 2017Unable to Obtain Readings; Device Operates Differently Than Expected; Unable to Obtain Readings; Device Operates Differently Than Expected
THE CUSTOMER REPORTED CABLES STOPPED WORKING. THE INFORMATION WAS NOT READING ON THE SCREEN. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7018402 ↗MalfunctionNov 10, 2017Unable to Obtain Readings; Device Operates Differently Than Expected; Unable to Obtain Readings; Device Operates Differently Than Expected
THE CUSTOMER REPORTED CABLES STOPPED WORKING. THE INFORMATION WAS NOT READING ON THE SCREEN. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7018400 ↗
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- 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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