MAUDE Adverse Event Report: VYAIRE MEDICAL INC. INFNT FLW LP,NCPAP,GENERATOR KIT WITOUT PRONGS + CIRCUIT X20; INFANT FLOW SIPAP CONSUMABLES/ACCESSORIES

Model Number	INFNT FLW LP,NCPAP,GENERATOR KIT WITOUT PRONGS + CIRCUIT X20
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been 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 that the infnt flw lp,ncpap,generator kit without prongs + circuit x20 experienced crack on lp generator due to proximal pressure was dropped during clinical using.As an intervention, lp generator was replaced.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Result of investigation: only some pictures were provided for investigation.A crack can be seen in the component.Therefore, reported defect was confirmed.Tried to duplicate the defect in the production line but it was not duplicated.The process was also reviewed yet there is no way to cause damage like the one observed in the pictures.

• Brand Name: INFNT FLW LP,NCPAP,GENERATOR KIT WITOUT PRONGS + CIRCUIT X20
• Common Device Name: INFANT FLOW SIPAP CONSUMABLES/ACCESSORIES
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12139971
• Report Number: 8030673-2021-00180
• Device Sequence Number: 14293253
• Product Code: BZD
• UDI-Device Identifier: 70846446005907
• UDI-Public: (01)70846446005907
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

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: INFNT FLW LP,NCPAP,GENERATOR KIT WITOUT PRONGS + CIRCUIT X20
• Device Catalogue Number: 26405-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention