MAUDE Adverse Event Report: VYAIRE MEDICAL VMAX; CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

Model Number VMAX ENCORE 22D

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Injury (2348)

Event Date 11/19/2018

Event Type  Injury  

Manufacturer Narrative

Several attempts have been made to retrieve the sample from the customer.At this time, vyaire has not received the suspected mouth piece for evaluation.Any additional information received from the customer will be included in a follow-up report.

Event Description

While using the vmax for pulmonary function testing, the patient's lips were sticking to the mouthpiece and causing their lips to bleed.

• Brand Name: VMAX
• Type of Device: CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8713841
• MDR Text Key: 148474182
• Report Number: 2021710-2019-10389
• Device Sequence Number: 1
• Product Code: BTY
• UDI-Device Identifier: 10846446021417
• UDI-Public: (01)10846446021417(11)20060601
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K942211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2018

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: VMAX ENCORE 22D
• Device Catalogue Number: 777405-101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2006
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other