MAUDE Adverse Event Report: VYAIRE MEDICAL FLEX CKT 38IN HTD WIRE F&P 730 BX 4; VENTILATOR, HIGH FREQUENCY

Model Number	FLEX CKT 38IN HTD WIRE F&P 730 BX 4
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vyaire medical was unable to verify the customer's reported issue.The suspect device is not available for return, as it was discarded.Based on the investigation the reported defect was not confirmed since no picture or sample was provided.Also, we are unable to review the device history record for any issue related to this customer report since the lot number was not provided.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical that the 771374 771374 flex ckt 38in htd wire f&p 730 bx 4, heated circuits with the (b)(4) stopped working.There was a patient involved in this reported event, however, no harm was noted as they were able to remove the patient from the ventilator and bagged the patient to replace the circuit.

• Brand Name: FLEX CKT 38IN HTD WIRE F&P 730 BX 4
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11269909
• Report Number: 8030673-2021-00147
• Device Sequence Number: 3287007
• Product Code: LSZ
• UDI-Device Identifier: 20846446003380
• UDI-Public: (01)20846446003380
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P890057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2021

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: FLEX CKT 38IN HTD WIRE F&P 730 BX 4
• Device Catalogue Number: 771374
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 02/02/2021
• 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