MAUDE Adverse Event Report: VYAIRE MEDICAL 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

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2020

Event Type  Injury  

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 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
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10029512
• MDR Text Key: 192149813
• Report Number: 3006783791-2020-00001
• Device Sequence Number: 1
• Product Code: BTM
• UDI-Device Identifier: 10885403220456
• UDI-Public: (01)10885403220456(10)0004093435
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention