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

Device Problem Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2021

Event Type  malfunction  

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 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
• Type of Device: HYPERINFLATION BAG SYSTEM
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• MDR Report Key: 12643816
• MDR Text Key: 281096053
• Report Number: 8030673-2021-00202
• Device Sequence Number: 1
• Product Code: BZD
• UDI-Device Identifier: 10190752145894
• UDI-Public: (01)10190752145894(10)4179972
• Combination Product (y/n): N
• PMA/PMN Number: K911465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1