MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE BABY SAFE FLOW-INFLATING RESUSCITATION DEVICE LITER BAG, 60CM H2O PO; HYPERINFLATION BAG SYSTEM

Model Number	AIRLIFE¿ BABY SAFE FLOW-INFLATING RESUSCITATION DEVICE ½ LITER BAG, 60CM H2O POP
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 baby safe hyp inf, 5l, 60cmh20, mano nrpr experienced manometer was stuck, not allowing the bag to refill properly.As of this time, there is no information regarding patient involvement associated with this reported event.

• Brand Name: AIRLIFE BABY SAFE FLOW-INFLATING RESUSCITATION DEVICE LITER BAG, 60CM H2O PO
• Common Device Name: HYPERINFLATION BAG SYSTEM
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• MDR Report Key: 12643816
• Report Number: 8030673-2021-00202
• Device Sequence Number: 11625949
• Product Code: BZD
• UDI-Device Identifier: 10190752145894
• UDI-Public: (01)10190752145894(10)4179972
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K911465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AIRLIFE¿ BABY SAFE FLOW-INFLATING RESUSCITATION DEVICE ½ LITER BAG, 60CM H2O POP
• Device Catalogue Number: 5504B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1