MAUDE Adverse Event Report: AIRLIFE¿ ADULT MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, ADULT MASK, 7' O2; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number	AIRLIFE¿ ADULT MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, ADULT MASK, 7' O2
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information was received.
Event or Problem Description
The customer reported that after successfully intubating the patient in the cardio-thoracic icu, the team was unable to separate the mask from the resuscitation bag of airlife adult manual resuscitator to ventilate via the endotracheal tube.The team was able to resume ventilation and oxygenation with a new resuscitation bag.At this time, patient outcome is unknown.

• Brand Name: AIRLIFE¿ ADULT MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, ADULT MASK, 7' O2
• Common Device Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• MDR Report Key: 10029512
• Report Number: 3006783791-2020-00001
• Device Sequence Number: 3881795
• Product Code: BTM
• UDI-Device Identifier: 10885403220456
• UDI-Public: (01)10885403220456(10)0004093435
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2020

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: AIRLIFE¿ ADULT MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, ADULT MASK, 7' O2
• Device Catalogue Number: 2K7000
• Device Lot Number: 0004093435
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 05/06/2020
• 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): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention