MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS BABY SAFE FLOW-INFLATING RESUSCITATION DEVICE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	VITAL SIGNS¿ BABY SAFE FLOW-INFLATING RESUSCITATION DEVICE, FLOW-INFLATING TRANS
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be determined yet.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 an issue on vital signs¿ baby safe flow-inflating resuscitation device, flow-inflating transport, fresh gas elbow, 7' oxygen tubing, disposable.Occlusion was discovered between flex tube and elbow.The issue was detected during clinical use, but no harm was reported.As an intervention, the defective unit was replaced with the backup unit.
Additional Manufacturer Narrative
Result of investigation: vyaire medical was able to confirm the reported issue and determined that the root cause was related to the personnel / training - operator error - assembly.As a corrective and preventive action, all the personnel involved were retrained on procedures (b)(4) to carry out the cleaning properly.A mesh will be placed on the container where component 070-700024a is put after it was molded, to separate any pellet that could fall on the container.This action will be carried out under (b)(4).

• Brand Name: VITAL SIGNS BABY SAFE FLOW-INFLATING RESUSCITATION DEVICE
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 10608543
• Report Number: 8030673-2020-00120
• Device Sequence Number: 19531378
• Product Code: BZD
• UDI-Device Identifier: 10190752119109
• UDI-Public: (01)10190752119109
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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: VITAL SIGNS¿ BABY SAFE FLOW-INFLATING RESUSCITATION DEVICE, FLOW-INFLATING TRANS
• Device Catalogue Number: 5503EU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 11/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention