ECG Electrodes CBL ECG 5LEAD GRABBER, AAMI + SPO2, TELERecalls & reported problems
Philips Medical Systems Hsg · MX40 Patient Cable consists of 5-wire ECG lead set with integrated 8-pin SpO2 connector cable. Grabber leads, AAMI color coded (colored lead wires). Reusable. Cable length = 85 cm (33.5 .) 1 Sales unit= 1 cable. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884838013407), received between Sep 29, 2026 and Sep 29, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Imprecise or Erratic Results” (2 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.
Reports received per month
Most reported problems
Device problems
- Imprecise or Erratic Results2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Imprecise or Erratic Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937978 ↗MalfunctionSep 29, 2026Imprecise or Erratic Results
Philips received a complaint on a CBL ECG 5 lead Grabber AAMI + SpO2, Tele indicating the lead set was not working and was unable to provide appropriate rhythm; the readings were inaccurate. The device was in clinical use at the time the issue was discovered. There was no adverse or patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931739 ↗
Other DETECTOR AND ALARM, ARRHYTHMIA devices
- Reveal LINQ™ LNQ11Medtronic, Inc. · DETECTOR AND ALARM, ARRHYTHMIA1 recall7,581 reports
- Confirm Rx™ DM3500St. Jude Medical, Inc. · DETECTOR AND ALARM, ARRHYTHMIA2 recalls2 deaths5,149 reports
- Reveal LINQ TM LNQ11Medtronic, Inc. · DETECTOR AND ALARM, ARRHYTHMIA1 death1,592 reports
- Jot Dx™ DM4500St. Jude Medical, Inc. · DETECTOR AND ALARM, ARRHYTHMIA1 death1,005 reports
- Reveal LINQ™ LNQ11Medtronic, Inc. · DETECTOR AND ALARM, ARRHYTHMIA1 death930 reports
- LINQ II™ LNQ22Medtronic, Inc. · DETECTOR AND ALARM, ARRHYTHMIA2 recalls673 reports
- Reveal LINQ™ LNQ11Medtronic, Inc. · DETECTOR AND ALARM, ARRHYTHMIA431 reports
- Reveal LINQ™ LNQ11Medtronic, Inc. · DETECTOR AND ALARM, ARRHYTHMIA1 recall343 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.
How reports and recalls are matched · Editorial policy · Report an error on this page