Vyaire V-178602Recalls & reported problems

Jaeger Medical GmbH · Vyntus ONE · 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 04250892904702), received between Nov 27, 2024 and Nov 27, 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

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.

MalfunctionNov 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 30-OCT-2024 VYAIRE WAS INFORMED BY A CUSTOMER THAT THE USS MODULE BECAME DISLODGED FROM THE FPV BLOCK WHEN PATIENT ACCIDENTLY PULLED IT OUT DURING SPIROMETRY TEST. THE MODULE DID NOT HIT THE FLOOR BUT THE USS CABLE DISCONNECT WHICH CAUSED DAMAGE TO THE CABLE. NO PATIENT HARM OCCURRED AND PATIENT DID NOT REQUIRE ANY MEDICAL ATTENTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20796880 ↗

Device details

UDI-DI	`04250892904702`
Brand	Vyaire
Model	V-178602
Company	Jaeger Medical GmbH
Product code	BZC · Calculator, Pulmonary Function Data
Class	Class 2
FDA submission	K181524
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): Pulmonary function analysis system, adult

A device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].

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