Vyaire V-378540Recalls & reported problems

Jaeger Medical GmbH · Vyntus BODY · 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 04250892905693), received between Nov 21, 2024 and Nov 21, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Detachment of Device or Device Component1
Environmental Particulates1

Patient problems

Insufficient Information1

Recent adverse event reports

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

MalfunctionNov 21, 2024Detachment of Device or Device Component; Environmental Particulates; Detachment of Device or Device Component; Environmental Particulates
ON 22-OCT-2024 VYAIRE WAS INFORMED BY A CUSTOMER, THAT THE USS MODULE WAS DROPPED WHILE CONDUCTING THE TEST ON PATIENT AND THE USS CABLE DISLODGE FROM THE SENSOR LEAVE ONLY THE CABLE COVER ON IT. THE CUSTOMER RECONNECTED THE CABLE TO THE USS SENSOR WITHOUT TURNING OFF THE VYNTUS BODY. DUE TO THE MISSING CABLE COVER THIS RESULTED IN SMOKE COMING OUT OF THE FPV MODULE. THERE WAS NO PATIENT HARM REPORTED, FURTHER INFORMATION IS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20746540 ↗

Device details

UDI-DI	`04250892905693`
Brand	Vyaire
Model	V-378540
Company	Jaeger Medical GmbH
Product code	BZC · Calculator, Pulmonary Function Data
Class	Class 2
FDA submission	K190853
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 28, 2025

Device type (GMDN): Whole-body plethysmograph

A graphic recorder designed for determining and registering airway resistance and thoracic gas volume to assess pulmonary function. It includes an airtight body chamber and transducers that allow the recording of chamber pressure versus airflow, and chamber pressure versus mouth pressure, to determine the airway resistance. Thoracic gas volume is typically determined by recording the chamber and airway pressures simultaneously with the airway open and with the airway occluded. It may also be possible to determine the instantaneous flow by recording the pulmonary capillary blood flow with the device.

Other Calculator, Pulmonary Function Data devices

Vyaire V-707327
Jaeger Medical GmbH · Calculator, Pulmonary Function Data
1 recall0 reports
Vyaire V-178500-13
Jaeger Medical GmbH · Calculator, Pulmonary Function Data
6 reports
Vyaire V-178500
Jaeger Medical GmbH · Calculator, Pulmonary Function Data
4 reports
Vyaire V-178603
Jaeger Medical GmbH · Calculator, Pulmonary Function Data
3 reports
Jaeger 172520
Jaeger Medical GmbH · Calculator, Pulmonary Function Data
2 reports
Vyaire V-178601
Jaeger Medical GmbH · Calculator, Pulmonary Function Data
2 reports
Vyaire V-707960
Jaeger Medical GmbH · Calculator, Pulmonary Function Data
2 reports
Jaeger V-175423
Jaeger Medical GmbH · Calculator, Pulmonary Function Data
2 reports

All Calculator, Pulmonary Function Data devices →

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