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

Model Number OBS, MASTERSCREEN PFT ESSENTIAL WITH BODY

Device Problem Overheating of Device (1437)

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

Event Date 04/26/2022

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).The pneumotach overheating in the box was found to be defective and will not be returned to vyaire medical for analysis.Vyaire medical will be replaced the defective part as ordered.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.

Event Description

The customer reported to vyaire medical pneumotach overheating within the jaegar body box.The reporter confirmed that there is no patient involvement associated on this event.

• Brand Name: MASTERSCREEN
• Type of Device: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 14492529
• MDR Text Key: 300431503
• Report Number: 9615102-2022-00123
• Device Sequence Number: 1
• Product Code: BZC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122699
• 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
• Type of Report: Initial
• Report Date: 04/26/2022

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: OBS, MASTERSCREEN PFT ESSENTIAL WITH BODY
• Device Catalogue Number: 172500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2009
• 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