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

Device Problem Circuit Failure (1089)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2021

Event Type  Injury  

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 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
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada v?a de la producci?n; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 11269909
• MDR Text Key: 230019348
• Report Number: 8030673-2021-00147
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 20846446003380
• UDI-Public: (01)20846446003380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention