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

Model Number VYNTUS BODY

Device Problem Mechanical Problem (1384)

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

Event Date 06/15/2021

Event Type  malfunction  

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 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
• Type of Device: CALCULATOR, PULMONARY FUNCTION DATA
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618
• MDR Report Key: 12146945
• MDR Text Key: 260938958
• Report Number: 2021710-2021-14184
• Device Sequence Number: 1
• Product Code: BZC
• UDI-Device Identifier: 04250892904689
• UDI-Public: (01)04250892904689(11)20210528
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: VYNTUS BODY
• Device Catalogue Number: V-178500-13
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2021
• 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