MasimoSET® uSpO2™ Pulse Oximetry Cable for GE ApexPro® FH 3578Recalls & reported problems
Masimo Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00843997007498), received between May 23, 2019 and May 23, 2019 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Sensing Intermittently” (5 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 Intermittently5
Patient problems
- No Consequences Or Impact To Patient5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2019Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE CABLE HAS AN INTERMITTENT OPERATION; ANY SLIGHT MOVEMENT OF THE CABLE CAUSES A DISCONNECT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8637570 ↗MalfunctionMay 23, 2019Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE CABLE HAS AN INTERMITTENT OPERATION; ANY SLIGHT MOVEMENT OF THE CABLE CAUSES A DISCONNECT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8637569 ↗MalfunctionMay 23, 2019Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE CABLE HAS AN INTERMITTENT OPERATION; ANY SLIGHT MOVEMENT OF THE CABLE CAUSES A DISCONNECT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8637565 ↗MalfunctionMay 23, 2019Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE CABLE HAS AN INTERMITTENT OPERATION; ANY SLIGHT MOVEMENT OF THE CABLE CAUSES A DISCONNECT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8637564 ↗MalfunctionMay 23, 2019Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE CABLE HAS AN INTERMITTENT OPERATION; ANY SLIGHT MOVEMENT OF THE CABLE CAUSES A DISCONNECT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8637562 ↗
Other Oximeter devices
- Trilogy Trilogy100 Ventilator, InternationalRespironics, Inc. · Oximeter8 deaths2,493 reports
- Trilogy Trilogy 202 Ventilator, United StatesRespironics, Inc. · Oximeter2 deaths1,594 reports
- 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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