Sensor External Flow Sensor CableRecalls & reported problems
Respironics, Inc. · External Flow Sensor Cable · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00606959051812), received between Mar 19, 2022 and Dec 15, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem2
- Electrical /Electronic Property Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 15, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR HAD AN EXTERNAL SENSOR FAILURE. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE THE REPORTED ISSUE WAS CONFIRMED. THE SENSOR CABLE WAS REPLACED TO CORRECT THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18341511 ↗MalfunctionApr 27, 2022Mechanical Problem; Mechanical Problem
A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE EXTERNAL FLOW SENSOR CABLE MALFUNCTIONED. THE CABLE WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14220739 ↗MalfunctionMar 19, 2022Mechanical Problem; Mechanical Problem
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR AN EXTERNAL FLOW SENSOR ALARM CONDITION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS EVALUATED BY A MANUFACTURER'S SALES REPRESENTATIVE IN THE HOME. THE DEVICE'S EXTERNAL FLOW SENSOR CABLE WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13824904 ↗
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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