MAUDE Adverse Event Report: MASK OXYGEN ADULT 3-IN-1 W/ VENT AND TBG; MASK, OXYGEN, NON-REBREATHING

Model Number MASK OXYGEN ADULT 3-IN-1 W/ VENT AND TBG

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2020

Event Type  Injury  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.No root cause has been determined at this time, since the investigation is still ongoing.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that the non-rebreather bag was disconnected from the mask while connected to a patient.The nurse replaced the defective unit with a back up bag.The customer confirmed that there was no patient harm associated with the reported event.

Manufacturer Narrative

Result of investigation: the device history record (dhr) review did not show any deviations to manufacturer specification.For functionality failure, it is imperative to receive a sample to duplicate the failure as described.

• Brand Name: MASK OXYGEN ADULT 3-IN-1 W/ VENT AND TBG
• Type of Device: MASK, OXYGEN, NON-REBREATHING
• MDR Report Key: 10150911
• MDR Text Key: 195102090
• Report Number: 8030673-2020-00101
• Device Sequence Number: 1
• Product Code: KGB
• UDI-Device Identifier: 10190752116320
• UDI-Public: (01)10190752116320
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

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: MASK OXYGEN ADULT 3-IN-1 W/ VENT AND TBG
• Device Catalogue Number: 001203
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 08/10/2020
• Supplement Dates FDA Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention