MAUDE Adverse Event Report: VYAIRE MEDICAL HFOV 3100B VENTILATOR TUBING; VENTILATOR BREATHING CIRCUIT, SINGLE-USE

Model Number	HFOV 3100B VENTILATOR TUBING
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
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 hfov 3100b ventilator tubing experienced ventilator showing "oscillator stopped" alarm.Found damaged patient breathing circuit's diaphragm after use.The customer confirmed that there was no patient harm associated with the reported event.As an intervention, replaced patient breathing set and resume the ventilator.
Additional Manufacturer Narrative
Result of investigation: some pictures were provided for the investigation.They were observed and we can see that a part of the membrane is detached from bellow.Therefore, reported defect was confirmed.

• Brand Name: HFOV 3100B VENTILATOR TUBING
• Common Device Name: VENTILATOR BREATHING CIRCUIT, SINGLE-USE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12715940
• Report Number: 8030673-2021-00211
• Device Sequence Number: 16507543
• Product Code: LSZ
• UDI-Device Identifier: 50190752155150
• UDI-Public: (01)50190752155150(10)0004092095
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPTED
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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: HFOV 3100B VENTILATOR TUBING
• Device Catalogue Number: 11744-850K
• Device Lot Number: 0004092095
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown