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

Model Number 172520

Device Problems Component Incompatible (1108); Contamination /Decontamination Problem (2895)

Patient Problems Discomfort (2330); Sore Throat (2396)

Event Date 06/19/2023

Event Type  malfunction  

Event Description

An incident was reported to vyaire medical by the copenhagen university hospital associated with the device masterscreen pft: during a spirometry measurement, a male patient performed an inhalation maneuver with the ms pft and had difficulties breathing afterwards.There was no medical intervention or treatment necessary.The patient was professionally observed during the short period when he had difficulties breathing.The customer also indicated that there was an unpleasant smell during the measurement.

Manufacturer Narrative

A preliminary investigation was initiated to identify possible causes for the incident, but could not be fully performed as there was not enough data in the initial report to investigate.More information is necessary and a request was sent to the customer.The customer was also requested to send the components involved in the incident back to vyaire for review in our failure analysis lab.Further investigation will be conducted once new information is available and a supplemental report will be submitted upon closure of the investigation.H3 other text : device not yet returned, waiting for arrival.

Manufacturer Narrative

The customer sent the masterscreen pft pro device, the pressure reducer and connectors back for investigation.The in-house failure analysis lab came to the following result.It is mandatory to utilize teflon tubing and stainless steel regulators and connectors when using no gas.The customer used a connector which is not made out of stainless steel and which chemically reacted with the no gas.Greenish powder deposits of the reaction were found on the reducing nipple of the connector and on the balloon valve mounting stand of the tube adapter.The tube adapter is always connected to the re-breathing bag and will further react with the remaining no gas in the system ¿ especially when a previously dlno measurement was aborted and the system was not flushed with o2.No will break down into nox with the o2 in the bag and create decomposition products which will remain in the bag and can be breathed in during the next measurement.This hazardous situation appeared due to several reasons.The customer did not follow the instructions and did not use a stainless connector as defined in information bulletin 20171103tm.During the use of the device the customer did not open the valve of the o2 gas cylinder to flush the system.Due to the missing o2 supply, the balloon valves were not inflated creating a path to the re-breathing bag, where old no gas from the last aborted test was degrading.Part of this residual gas was inhaled by the patient during the spirometry.The customer is supposed to regularly visually inspect the system.The residuals are obvious and could have easily been spotted; leading to the conclusion that device maintenance was insufficiently done.Another contributory factor is, that the change from 400ppm no up to 1200ppm no gas in 2017 was issued by a software information bulletin.Part of the change is the introduction of teflon tubes and a stainless steel connectors.The impact and risk of this change was communicated to the customer in this bulletin to make sure that all unsuitable parts (pur tube and chromed brass connectors) should be exchanged by suitable and appropriate parts and that the unsuitable parts should not be installed by mistake.All described causes need to happened to create the hazardous situation that degradation of no + o2 remains in the re-breathing bag and can be inhaled.The probability that this situation happens and leads to harm is negligible.No reportable adverse event or death happened.The risk assessment resulted in a possible critical severity of harm.The probability of the situation leading to the harm (p2) is somewhat likely.Thus, this malfunction is reportable to the fda as it is not unlikely to cause or contribute to a death or serious injury if the malfunction were to recur.The customer got a temporary system until he buys the correct parts.

• Brand Name: JAEGER
• Type of Device: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer (Section G): VYAIRE MEDICAL GMBH
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17389655
• MDR Text Key: 319864836
• Report Number: 9615102-2023-00135
• Device Sequence Number: 1
• Product Code: BZC
• UDI-Device Identifier: 04250892905112
• UDI-Public: (01)04250892905112(11)090918
• 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
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

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: 172520
• Device Catalogue Number: 172520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 06/27/2023
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2009
• 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
• Patient Outcome(s): Other
• Patient Sex: Male