MAUDE Adverse Event Report: VYAIRE MEDICAL JAEGER; CALCULATOR, PULMONARY FUNCTION DATA

Model Number V-175420

Device Problems Mechanical Problem (1384); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

A vyaire support representative went on-site to evaluate the suspect device.The support representative performed the work order and was able installed the supplied demand valve.After testing the new demand valve with different increase volumes, all maneuvers were carried out properly by the new demand valve and the issue was resolved.The representative checked and tested the device through calibrations and test measurements and returned the device to service specifications.

Event Description

The customer reported during the masterscreen body/diffusion testing.The demand valve leaks.The customer reported after inspiration the patient experienced (nausea) sickness, gag reflex, and "overblown" lung.The customer reported the shutter does not open adequately after exposure time and the patients exhales next to the mouthpiece.The customer reported being unable to carry out measurements and reported the most likely cause of the issue is the demand valve assembly.The customer reported the patient left the hospital without any further action (no surgery, no treatment).The customer reported there is no patient injury associated with the event.

• Brand Name: JAEGER
• Type of Device: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg, 97204 ; GM 97204
• Manufacturer Contact: stanley tan ; 510 technology drive; irvine, CA 92618 ; 7149193324
• MDR Report Key: 8847823
• MDR Text Key: 152941748
• Report Number: 9615102-2019-00107
• Device Sequence Number: 1
• Product Code: BZC
• UDI-Device Identifier: 04250892900216
• UDI-Public: (01)04250892900216
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V-175420
• Device Catalogue Number: 175452-13
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other