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Sensor External Flow Sensor w/Cable,Ped/InfantRecalls & reported problems

Respironics, Inc. · External Flow Sensor w/Cable, Pediatric / Infant · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959050822), received between Feb 2, 2022 and Feb 2, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

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.

Most reported problems

Device problems

  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 2, 2022Mechanical Problem; Mechanical Problem

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S FLOW SENSOR WOULD NOT PICK UP A SIGNAL. THERE WAS NO HARM OR INJURY REPORTED. THE COMPONENT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO MALFUNCTION COULD BE CONFIRMED. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13422770 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.