MAUDE Adverse Event Report: VYAIRE MEDICAL HOTWIRE FLOW,SENSOR,NEONATAL; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	HOTWIRE FLOW,SENSOR
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to vyaire medical that the hotwire flow,sensor,neonatal one or two of the hot wire flow sensor that one of her customer is using is not working properly.There are 2 flow sensors.One is auto cycling, and the other is "not recognized" by the actual ventilator.As of this time, there is no information about patient involvement associated with this reported event.
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).The suspect device was returned and evaluation is anticipated but not yet begun.Once a final investigation is complete, a follow-up report will be submitted.
Additional Manufacturer Narrative
Result of investigation: vyaire failure analysis was able to duplicate the reported issue avea does not recognize the sensor problem.Received hotwire flow sensors p/n 16465 lot# ca0930-018 and received hotwire flow sensors p/n 16465 lot# ca1201-023.Upon connection of the uut's "prox.Flow sensor ready, zero sensor recommended" did not display on uim per specification.With the monitoring screen accessed, the uim did not respond to either sensor cables with the calibration screen when the "zero sensor" button was selected.The uut's were unable to zero, also hot wire flow sensor verification was performed per test standard (b)(4) section 7.7.5 and failed verification.Investigation revealed additional problem with contamination on hwfs sensor filaments causing sensor failure.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: HOTWIRE FLOW,SENSOR,NEONATAL
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 13114923
• Report Number: 2021710-2021-15313
• Device Sequence Number: 14626909
• Product Code: CBK
• UDI-Device Identifier: 10846446001198
• UDI-Public: (01)10846446001198
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K103211
• 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): 09/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HOTWIRE FLOW,SENSOR
• Device Catalogue Number: 16465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown