MAUDE Adverse Event Report: VYAIRE MEDICAL INFANT FLOW LP NCPAP GENERATOR WITHOUT PRONGS; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	PACKAGE ASSEMBLY,GENERATOR WITHOUT PRONGS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: 81 other ¿ 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 becomes available.H3 other text : device not returned yet.
Event or Problem Description
It was reported to vyaire medical that the 7772000lp package assembly,generator without prongs broke in half while use on a baby.Furthermore, there was no harm done to the patient.
Additional Manufacturer Narrative
Result of investigation: customer sent photos of the fg part number 7772000lp with lot number unknown for the investigation.In the photos received, we can appreciate that the subcomponent generator part number cf75-113 is separated.Subsequently, customer sent 1 opened physical sample of the fg part number 7772000lp with lot number unknown for the investigation.A visual inspection was performed by quality personnel from assembly area according to pqas 7772000lp etal finding subcomponent generator part number cf75-113 separated, therefore finding the physical sample not acceptable.Additionally, the device history record should be reviewed as part of the investigation, however, as lot number was not provided for the investigation, we cannot review the device history record.Additionally, the initial report submitted under vyaire medical file identification: (b)(4) and mfr report # 8030673-2023-00349 is a duplicate of the report submitted under mfr report #8030673-2023-00350.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: INFANT FLOW LP NCPAP GENERATOR WITHOUT PRONGS
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; mexicali 21397 ; MX 21397
• Manufacturer Contact: erin salbilla ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17627949
• Report Number: 8030673-2023-00350
• Device Sequence Number: 14986388
• Product Code: BZD
• UDI-Device Identifier: 10190752152687
• UDI-Public: (01)10190752152687
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K031745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

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: PACKAGE ASSEMBLY,GENERATOR WITHOUT PRONGS
• Device Catalogue Number: 7772000LP
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown