MAUDE Adverse Event Report: VYAIRE MEDICAL MASK 3-IN-1 HI-CONC O2 ADULT W/7FT O2; ADULT OXYGEN MASK

Catalog Number 001210

Device Problem No Flow (2991)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Any additional information provided by the customer will be included in a follow up report.At this time, vyaire has not received the suspect device/component for evaluation.Due to device unavailability, no further evaluation can be completed a this time.

Event Description

It was reported to vyaire that the oxygen reservoir bag did not inflate properly.The customer reported potential patient harm associated with the reported issue.The patient "desated" and was unable to complete his regular 6 minute walk.The reported malfunction caused the patients saturation to drop to 61%.No further harm was noted.

Manufacturer Narrative

Correction: was not initially selected from the previous medwatch report.Corrected vyaire's manufacturer address.Results of investigation: one sample was received by vyaire medical quality team for further investigation.Upon investigation, it has been identified the assembly method of the gaskets is not clearly defined during the manufacturing process.This issue will be internally investigated within vyaire.

Event Description

Oxygen reservoir bag does not inflate properly.Disks over vents appear to be to rigid which does not allow for expiration.One way valve does not allow for oxygen to be breathed in from the reservoir bag and bag does not move even when used on a healthy person.The issue caused a pulmonary fibrosis patient awaiting lung transplant to desaturate to 61% on his regular 6 minute walk.The patient was brought back to a chair and began to recover.However, after eight minutes of recovery the saturation was still low at 70%.Activity was seized and patient put onto regular manufacturer's mask.

• Brand Name: MASK 3-IN-1 HI-CONC O2 ADULT W/7FT O2
• Type of Device: ADULT OXYGEN MASK
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8038503
• MDR Text Key: 126155755
• Report Number: 8030673-2018-00016
• Device Sequence Number: 1
• Product Code: KGB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 001210
• Device Lot Number: 0004034820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention