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

Model Number MS-PFT PRO/APS

Device Problem Insufficient Information (3190)

Patient Problems Low Blood Pressure/ Hypotension (1914); Decreased Respiratory Rate (2485)

Event Date 05/27/2022

Event Type  malfunction  

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.".

Event Description

It was reported to vyaire medical that during provocation the patient felt unwell during aps measurement on the of ms-pft pro/aps.The patient felt a lot of pressure on her chest, dropped her eyes, turned away and started snoring.The allergy medication was discontinued in time.The patients legs were raised with a blood pressure of 71/52 mmhg and a heart rate of 51 bpm.A few minutes later was measured again with a blood pressure of 90/60 mmhg and a heart rate of 64 bpm.The patient was sent to the emergency room for observation.

Manufacturer Narrative

A3, g3, h1, h3, h6, h10.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 complained about chest pressure but the health care professional continued the measurement.The ifu refers to two guidelines stating that the healthcare professional should be familiar with the treatment of airway obstructions and asthmatic attacks (page 140).Chest tightness is listed in the ats guidelines as a symptom.According to the ers airway responsiveness article, the patient should be instructed to discontinue inhalation if symptoms become troublesome.As a conclusion, an use error by the healthcare professional led to the fainting of the patient.The risk is addressed in the risk management file of the device.The use error poses an acceptable health risk, thus not reportable.B1, b3, d9, h11 - b1: no malfunction of the device because it functioned as intended.Use error.

• 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: 15090493
• MDR Text Key: 296466374
• Report Number: 9615102-2022-00125
• 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
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MS-PFT PRO/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: 02/03/2023
• Supplement Dates FDA Received: 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 Outcome(s): Required Intervention
• Patient Sex: Female