Jaeger 171500Recalls & reported problems

Jaeger Medical GmbH · MasterScreen Paed · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 04250892900414), received between Jul 31, 2020 and Jul 31, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Electrical /Electronic Property Problem1

Patient problems

No Patient Involvement1

Recent adverse event reports

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

MalfunctionJul 31, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE MASTERSCREEN DEVICE WAS FOUND TO HAVE A BURNED CIRCUIT BOARD PARTS INSIDE THE SYSTEM BOX WHEN THEY TURNED ON THE POWER DURING INSTALLATION. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Patient Involvement
MAUDE report 10353884 ↗

Device details

UDI-DI	`04250892900414`
Brand	Jaeger
Model	171500
Company	Jaeger Medical GmbH
Product code	CCM · Plethysmograph, Pressure
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	May 28, 2025

Device type (GMDN): Pulmonary function analysis system, paediatric

A computerized instrument designed to assess lung volume, flow, and mechanical parameters (including airway compliance and resistance) in young children and infants. It is different from an adult version in absolute dimensions and in the special procedures required for adaption to the pediatric patient (e.g., use of a small constant-volume chamber in which the infant reclines for plethysmography, use of a pressure jacket to obtain forced exhalation); also, parameters that require subject cooperation (e.g., vital capacity, forced expiratory volume) can't be determined. The device is used for pulmonary function testing in diagnostic studies and for evaluation of diseases and chest deformities.

Other Plethysmograph, Pressure devices

MGC Diagnostics 830008-902
Medical Graphics Corporation · Plethysmograph, Pressure
2 reports

All Plethysmograph, Pressure devices →

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.

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