uSpO2 Pulse Oximetry Cable for GE ApexPro® CH, CARESCAPE™ Telemetry T4 & T14 3449Recalls & reported problems
Masimo Corporation · uSpO2 Pulse Oximetry Cable for GE ApexPro® CH, CARESCAPE™ Telemetry T4 & T14 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00843997011433), received between Oct 25, 2019 and Nov 14, 2022 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Sensing Intermittently” (10 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 Intermittently10
- Low Readings3
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2022Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED INTERMITTENT CONNECTION OR NOT WORKING AT ALL. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15794971 ↗MalfunctionNov 14, 2022Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED INTERMITTENT CONNECTION OR NOT WORKING AT ALL. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15794905 ↗MalfunctionNov 14, 2022Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED INTERMITTENT CONNECTION OR NOT WORKING AT ALL. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15794892 ↗MalfunctionJan 28, 2022Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE DEVICE WORKED INTERMITTENTLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13389557 ↗MalfunctionJan 7, 2022Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED INTERMITTENT SIGNAL FOUND DURING TESTING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13197516 ↗MalfunctionJan 7, 2022Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED INTERMITTENT SIGNAL FOUND DURING TESTING. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13197515 ↗MalfunctionDec 30, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE DEVICE WAS INTERMITTENT. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13122394 ↗MalfunctionDec 30, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE DEVICE WAS INTERMITTENT. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13122390 ↗MalfunctionNov 7, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED SHORTAGES IN THE CORD THEN IT STOPPED WORKING OVER THE WEEKEND. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12763476 ↗MalfunctionSep 10, 2021Low Readings; Low Readings
THE CUSTOMER REPORTED LOW READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12455360 ↗MalfunctionSep 10, 2021Low Readings; Low Readings
THE CUSTOMER REPORTED LOW READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12455320 ↗MalfunctionSep 10, 2021Low Readings; Low Readings
THE CUSTOMER REPORTED LOW READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12455290 ↗MalfunctionOct 25, 2019Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THAT THE DEVICE WAS INTERMITTENT. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9241366 ↗
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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