HUDSON RCI IPN049141Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14026704626523), received between Feb 22, 2021 and Sep 30, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2021Break; Contamination; Break; Contamination

  CUSTOMER REPORTED THAT "REPORTED BY MR. KUMAR PILLAY ,PHYSIOTHERAPIST S DEORAJ , WAS GIVING PHYSIOTHERAPY TREATMENT TO A PATIENT IN SURGICAL WARD, DISCOVERED THAT THE TRIFLO INCENTIVE SPIROMETER HAD SMALL BROKEN PIECES STUCK IN, PREVENTING THE SECOND AND THIRD BALL FROM GOING UP DURING USE". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE". NEW DEVICE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12554751 ↗
• MalfunctionAug 6, 2021Break; Break

  IT WAS REPORTED THAT "A PATIENT DREW ATTENTION TO HIMSELF THAT HE FELT SOMETHING HARD IN HIS MOUTH WHEN USING THE BREATHING TRAINER. IT WAS A SMALL PLASTIC PIECE. ORIGIN CANNOT BE CLEARLY DETERMINED". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288013 ↗
• MalfunctionFeb 22, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THE "BALLS DID NOT MOVE". NO PATIENT HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362500 ↗