MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 5; MASK, GAS, ANESTHETIC

Catalog Number R6850WS

Device Problems Break (1069); Filling Problem (1233)

Patient Problem Insufficient Information (4580)

Event Date 09/07/2021

Event Type  malfunction  

Event Description

The vital sign adult face mask with adjustable air cushion size 5 wouldn't fill up with air and little pieces broke off into the chamber.

• Brand Name: VITAL SIGNS ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 5
• Type of Device: MASK, GAS, ANESTHETIC
• Manufacturer (Section D): VYAIRE MEDICAL; 1100 bird center drive; palm springs CA 92262
• MDR Report Key: 12744601
• MDR Text Key: 279863516
• Report Number: 12744601
• Device Sequence Number: 1
• Product Code: BSJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: R6850WS
• Device Lot Number: 1121126
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2021
• Date Report to Manufacturer: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA