MAUDE Adverse Event Report: VYAIRE MEDICAL INSPIRATORY LINE HTD 8FT ADULT 20/CS; HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Model Number INSPIRATORY LINE HTD 8FT ADULT 20/CS

Device Problem Fire (1245)

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

Event Date 02/09/2022

Event Type  malfunction  

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 Description

It was reported to vyaire medical that the 4681-504-inspiratory line htd 8ft adult 20/cs started to burned while connected to a patient.The customer confirm that there is no harm associated with the reported event.

Manufacturer Narrative

Result of investigation- the sample was visually inspected and it was found that the wire is burned and the wire does not contain the terminal connector with the high current connector, hence the sample was received incomplete.The reported issue was confirmed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: INSPIRATORY LINE HTD 8FT ADULT 20/CS
• Type of Device: HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
• 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: 14116193
• MDR Text Key: 289313369
• Report Number: 8030673-2022-00241
• Device Sequence Number: 1
• Product Code: BZE
• UDI-Device Identifier: 10885403039539
• UDI-Public: (01)10885403039539(10)0004201733
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INSPIRATORY LINE HTD 8FT ADULT 20/CS
• Device Catalogue Number: 4681-504
• Device Lot Number: 0004201733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1