MAUDE Adverse Event Report: VYAIRE MEDICAL INC. VYNTUS BODY; CALCULATOR, PULMONARY FUNCTION DATA

Model Number	VYNTUS BODY
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification:(b)(4).A vyaire field service representative(fsr) evaluated the device onsite and installed a replacement door.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The service technician reported that the door of the vyntus body exploded on his hands during installation.The service technician did not sustain any injuries.There was no patient involvement associated with the reported event.

• Brand Name: VYNTUS BODY
• Common Device Name: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12146945
• Report Number: 2021710-2021-14184
• Device Sequence Number: 17141076
• Product Code: BZC
• UDI-Device Identifier: 04250892904689
• UDI-Public: (01)04250892904689(11)20210528
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K190853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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
• Operator of Device: Health Professional
• Device Model Number: VYNTUS BODY
• Device Catalogue Number: V-178500-13
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1