MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH VYNTUS ONE-PFT PC; CALCULATOR, PULMONARY FUNCTION DATA

Model Number VYNTUS ONE PFT

Device Problems Gas Output Problem (1266); Mechanical Problem (1384)

Patient Problems Dyspnea (1816); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2023

Event Type  malfunction  

Event Description

It was reported to vyaire medical that during n2 washout, the vyntus one f1 shutter was unable to switch into washout mode.The user stated that the patient could not breathe due to resistance.At this time, the customer has not provided any information regarding patient harm or injury associated with the reported event.

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.However, it sounds like when switching to 100% in n2 wash out, the shutter moves but there was no gas for the patient to inhale so tank was either empty, off, or the path the o2 travels was occluded.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.

Manufacturer Narrative

The most probable root cause is that the customer did not check the gas pressure before testing and the pressure has been too low.The customer was advised to switch the gas tank.The risk evaluation concluded that the patient will not be able to inhale through the mouthpiece due to the low gas pressure.The patient can come off the mouthpiece to breathe in.It represents an acceptable health risk.The reporting decision changed to not reportable after investigation.If the use error reoccurs it is unlikely to cause or contribute to a serious injury or death.

Event Description

No patient was harmed.

• Brand Name: VYNTUS ONE-PFT PC
• Type of Device: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7 hoechberg, 97; hoechberg 97204 ; GM 97204
• Manufacturer (Section G): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97201 ; GM 97201
• Manufacturer Contact: maren wiese ; leibnizstrasse 7; hoechberg, CA 97204 ; GM 97204
• MDR Report Key: 16280092
• MDR Text Key: 309189917
• Report Number: 9615102-2023-00132
• Device Sequence Number: 1
• Product Code: BZC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 02/01/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: VYNTUS ONE PFT
• Device Catalogue Number: 31783-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 02/01/2023
• Supplement Dates Manufacturer Received: 01/09/2023
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1