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

Model Number MS PFT PRO

Device Problems Smoking (1585); Electrical Shorting (2926)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2022

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).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 becomes available.

Event Description

It was reported to vyaire medical that the analyzer pump of the ms pft pro did not turn on when doing a gas calibration.The distributor checked the device and found that the analyzer fan was not on either.They also found a broken down fuse in the system box.This was replaced, but it broke down again immediately upon turning on the device.The fuse was replaced again, and the device was turned on without connecting to the computer and analyzer.The fuse broke down like before but with some smoke coming up.The computer turned on normally even without changing the fuse.They changed the fuse one last time, and this did not break.However, the fan or analyzer pump still did not turn on.No patient involvement.

Manufacturer Narrative

The conclusion of the investigation is that a defective pcba controller card resulted in blown fuses and analyzer pump not turning on.The malfunction poses an acceptable health risk to the user/bystander/operator.Hence the malfunction is not reportable after investigation.An exchange of v-708570 pcba controller card solved the issue.For this product malfunction, no trends were identified.The issue is further monitored.

• Brand Name: PRODUCT MASTERSCREEN PFT SES
• 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: 15480647
• MDR Text Key: 302766233
• Report Number: 9615102-2022-00127
• Device Sequence Number: 1
• Product Code: BZC
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K122699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MS PFT PRO
• Device Catalogue Number: MSPFT-SES
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 01/05/2023
• Supplement Dates FDA Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2016
• 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