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Jaeger 172520 (UDI 04250892905112)Recalls & reported problems

Jaeger Medical GmbH · MasterScreen PFT · 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 04250892905112), received between Jul 25, 2023 and Jul 25, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Incompatible” (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

  • Component Incompatible1
  • Contamination /Decontamination Problem1

Patient problems

  • Discomfort1
  • Sore Throat1

Recent adverse event reports

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

  • MalfunctionJul 25, 2023Component Incompatible; Contamination /Decontamination Problem; Component Incompatible; Contamination /Decontamination Problem

    AN INCIDENT WAS REPORTED TO VYAIRE MEDICAL BY THE COPENHAGEN UNIVERSITY HOSPITAL ASSOCIATED WITH THE DEVICE MASTERSCREEN PFT: DURING A SPIROMETRY MEASUREMENT, A MALE PATIENT PERFORMED AN INHALATION MANEUVER WITH THE MS PFT AND HAD DIFFICULTIES BREATHING AFTERWARDS. THERE WAS NO MEDICAL INTERVENTION OR TREATMENT NECESSARY. THE PATIENT WAS PROFESSIONALLY OBSERVED DURING THE SHORT PERIOD WHEN HE HAD DIFFICULTIES BREATHING. THE CUSTOMER ALSO INDICATED THAT THERE WAS AN UNPLEASANT SMELL DURING THE MEASUREMENT.

    Patient problems: Discomfort; Sore Throat

    MAUDE report 17389655 ↗

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