MAUDE Adverse Event Report: VYAIRE MEDICAL BOX,DISPOSABLE MOUTH PIECE; MOUTHPIECE, BREATHING

Model Number M/PIECES LG DISP BX150

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Injury (2348)

Event Date 03/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).At this time, vyaire has received the suspected mouthpiece.Details to determine the type of investigation are not yet available, but are being sought.Any additional information 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.

Manufacturer Narrative

The issue was internally investigated.Vyaire failure analysis lab received the part and parts were sent to the supplier.The supplier and manufacturer provided root cause and correction: root cause: manufacturer confirmed that they had initially stocked two similar materials and that the wrong material was picked for this batch.Correction: manufacturer confirmed that they no longer stock the other material so there will be no chance for confusion in the future.The oem has added a visual inspection requirement during receiving inspection to verify that the material is glossy.

• Brand Name: BOX,DISPOSABLE MOUTH PIECE
• Type of Device: MOUTHPIECE, BREATHING
• 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: 8724547
• MDR Text Key: 148906642
• Report Number: 2021710-2019-10388
• Device Sequence Number: 1
• Product Code: BYP
• UDI-Device Identifier: 20846446020240
• UDI-Public: (01)20846446020240
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M/PIECES LG DISP BX150
• Device Catalogue Number: 42157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Date Manufacturer Received: 04/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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