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
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/23/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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
• Common Device Name: MASK, OXYGEN, NON-REBREATHING
• MDR Report Key: 10150911
• Report Number: 8030673-2020-00101
• Device Sequence Number: 16654692
• Product Code: KGB
• UDI-Device Identifier: 10190752116320
• UDI-Public: (01)10190752116320
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 08/31/2020
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention