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

Model Number MS-PFT PRO/BODY/APS

Device Problem Insufficient Information (3190)

Patient Problems Dizziness (2194); Loss of consciousness (2418)

Event Date 06/10/2022

Event Type  malfunction  

Event Description

It was reported to vyaire medical that during provocation the patient felt unwell after the administration of the last/highest concentration of histamine on the of ms-pft pro/aps.The patient was unresponsive for 20 seconds.After administration of salbutamol the patient recovered slowly but still felt dizzy.The measured sao2 was 97-98% and the measured blood pressure was 117/79 mmhg.

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.".

Manufacturer Narrative

Device evaluation:g3,g6,h2,h6, and h10.Result of investigaion: the aps works as intended and is designed to stimulate the patient in order to find out when the lung reacts and breathing starts to be limited.This risk is addressed in risk management file 650712 10 for masterscreen pft, body-diff, aps, ios on line item c1.41.This risk is also addressed in the ifu (instructions for use).In the ifu, it is stated that the physician is in charge to determine the risk for the patient and as well to take care for emergency support.It is known that methacholine can have a side effect to the blood pressure.The dutch service team performed a technical check without any findings; there was no malfunction.The event is an expected and forseeable side effect.

Manufacturer Narrative

It is known that the treatment with a provocation system may potentially cause a reaction for some patients depending on the patient's health and individual respiratory system characteristics.This reaction is also dependent on the amount of histamine or provocation medicine administered by the healthcare professional during each test.During provocation measurement on the aps, the patient felt unwell and sensed his fainting.The patient didn't communicate his symptoms and so the health care professional continued the test as prescribed.Once the patient had symptoms, the test was terminated and the appropriate patient care and rescue medication was given.The symptoms are linked to the histamine inhalation, either directly as a histamine intolerance symptom and/or indirectly by the potential bronchoconstriction that it produced in this patient.There's no error linked to the measurement procedure, reaction of the health care professional or the medical device.The reaction of the patient is a known side effect of the provocation test.The risk is addressed in the risk management file of the device.The reaction poses an acceptable health risk.Classified as not an adverse event because the event is an expected and foreseeable side effect.

• Brand Name: MASTERSCREEN PFT
• Type of Device: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg, 97201 ; GM 97201
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15090494
• MDR Text Key: 296468065
• Report Number: 9615102-2022-00126
• Device Sequence Number: 1
• Product Code: BZC
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K122699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MS-PFT PRO/BODY/APS
• Device Catalogue Number: 27281-001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/24/2022
• Supplement Dates Manufacturer Received: 12/20/2022; 02/03/2023
• Supplement Dates FDA Received: 02/06/2023; 02/27/2023
• 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 Sex: Male