uSpO2 Pulse Oximetry Cable for GE ApexPro® CH, CARESCAPE™ Telemetry T4 & T14 3577Recalls & reported problems
Masimo Corporation · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Masimo uSpO2 pulse oximetry cable connects to GE ApexPro CH and CARESCAPE Telemetry monitors to send patient oxygen saturation readings. The 53 reports mostly describe the cable dropping in and out intermittently, stopping working, or its wire or outer jacket splitting, cracking or wearing out where it bends near the connector. No deaths or injuries were reported. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 53
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00843997007481), received between Sep 14, 2017 and Dec 30, 2021 — classified as 53 malfunctions.
The most frequently reported specific device problem is “Sensing Intermittently” (43 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 Intermittently43
- Loose or Intermittent Connection4
- Low Readings2
- Material Split, Cut or Torn2
- Break1
- Device Stops Intermittently1
- Disconnection1
- Inappropriate or Unexpected Reset1
Patient problems
- No Consequences Or Impact To Patient41
- No Clinical Signs, Symptoms or Conditions12
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
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 13122391 ↗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 12763540 ↗MalfunctionOct 19, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE USPO2 CABLE JACKET IS BENT NEAR THE CONNECTOR WHICH HAS CAUSED AN INTERMITTENT FUNCTIONAL ISSUE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12659047 ↗MalfunctionOct 19, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE USPO2 CABLE JACKET IS BENT NEAR THE CONNECTOR WHICH HAS CAUSED AN INTERMITTENT FUNCTIONAL ISSUE. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12659034 ↗MalfunctionSep 24, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE DEVICE STOPPED WORKING SUDDENLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12527547 ↗MalfunctionSep 24, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE DEVICE STOPPED WORKING SUDDENLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12527523 ↗MalfunctionSep 10, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset
THE CUSTOMER REPORTED THAT THE DEVICE SUDDENLY STOPPED WORKING. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12455326 ↗MalfunctionAug 25, 2021Sensing Intermittently; Material Split, Cut or Torn; Sensing Intermittently; Material Split, Cut or Torn
THE CUSTOMER REPORTED THE DEVICE WIRE IS STRIPPING FROM BEING BENT AND THE CABLE STOPPED WORKING WHILE ON THE CUSTOMER. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12367860 ↗MalfunctionAug 25, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE DEVICE IS NOT CONNECTING THROUGH TO MONITOR AND THE DEVICE STOPPED WORKING WHILE ON THE PATIENT. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12367858 ↗MalfunctionAug 20, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THAT THE USPO2 MODULE PROVIDED INTERMITTENT READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12350401 ↗MalfunctionAug 20, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THAT THE USPO2 MODULE PROVIDED INTERMITTENT READINGS. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12349609 ↗MalfunctionApr 15, 2021Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE CABLE ONLY WORKS INTERMITTENTLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11671836 ↗MalfunctionDec 30, 2020Low Readings; Low Readings
THE CUSTOMER REPORTED THE DEVICE IS PROVIDING LOW READINGS AND THE PLASTIC GUARD HAS BROKEN OFF. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11096515 ↗MalfunctionDec 18, 2020Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THAT THE SIGNAL DROPS WHEN CABLE IS MOVED. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11038272 ↗MalfunctionDec 18, 2020Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THAT THE SIGNAL DROPS WHEN CABLE IS MOVED. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11038260 ↗MalfunctionNov 24, 2020Low Readings; Low Readings
THE CUSTOMER REPORTED THAT THE READINGS WERE LOW. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10898806 ↗MalfunctionNov 24, 2020Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED AN INTERMITTENT CONNECTION. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10898453 ↗MalfunctionJan 24, 2020Incorrect Measurement; Material Separation; Incorrect Measurement; Material Separation
THE CUSTOMER REPORTED THE CABLE IS COMING APART AT THE SLEEVE, LEAVING A GAP WITH VISIBLE WIRE AND IS GIVING INACCURATE O2 READINGS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9630164 ↗MalfunctionMay 22, 2019Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE CABLE HAS AN INTERMITTENT SIGNAL LOSS. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8634669 ↗MalfunctionApr 3, 2019Break; Sensing Intermittently; Break; Sensing Intermittently
THE CUSTOMER REPORTED THAT THE DEVICE HAD "BAD STRAIN RELIEFS CAUSING THEM TO INTERMITTENTLY WORK, OR NOT WORK AT ALL." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8480651 ↗MalfunctionMar 1, 2019Loose or Intermittent Connection; Material Split, Cut or Torn; Loose or Intermittent Connection; Material Split, Cut or Torn
THE CUSTOMER REPORTED THAT THE DEVICE "HAS INTERMITTENT PROBLEM/DAMAGE STRAIN RELIEF".NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8383978 ↗MalfunctionFeb 27, 2019Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED THE DEVICE OPERATED INTERMITTENTLY. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8376356 ↗MalfunctionFeb 8, 2019Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED AN INTERMITTENT OPERATION, WHEN THE CABLE IS MOVED THE SIGNAL IS LOST. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8324113 ↗MalfunctionFeb 8, 2019Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED AN INTERMITTENT OPERATION, WHEN THE CABLE IS MOVED THE SIGNAL IS LOST. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8324075 ↗MalfunctionFeb 8, 2019Sensing Intermittently; Sensing Intermittently
THE CUSTOMER REPORTED AN INTERMITTENT OPERATION, WHEN THE CABLE IS MOVED THE SIGNAL IS LOST. NO PATIENT IMPACT OR CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8324066 ↗
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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