MAUDE Adverse Event Report: VYAIRE MEDICAL INC. BOXED PAT CIRCUIT ASSY,3100A,FLTRD,850L; VENTILATOR, HIGH FREQUENCY

Model Number BOXED PAT CIRCUIT ASSY,3100A,FLTRD,850L

Device Problem Material Too Soft/Flexible (4007)

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

Event Date 06/05/2022

Event Type  Injury  

Event Description

The customer reported that the plastic in which the boxed pat circuit assy,3100a,fltrd,850l is made from is not sufficiently rigid for its purpose.Their 3100a had a patient which was cutting out suddenly and not restarting.Upon checking, the tube between the ventilator and the humidifier was bent over, not allowing gas to get into the circuit.End user then repositioned the hose and taped it to the side of the 3100a for support.No harm is associated with the event.

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Manufacturer Narrative

Result of investigation: the suspect device is not available for return, as it was discarded after the treatment.Sample photo without lot number was sent for the investigation and in the picture it can be seen that the tube part was slightly bent.Therefore the defect reported by the customer was confirmed.

• Brand Name: BOXED PAT CIRCUIT ASSY,3100A,FLTRD,850L
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• 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: 14978478
• MDR Text Key: 295631003
• Report Number: 8030673-2022-00258
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 50190752159820
• UDI-Public: (01)50190752159820(10)0004188661
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

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: BOXED PAT CIRCUIT ASSY,3100A,FLTRD,850L
• Device Catalogue Number: 29028-011
• Device Lot Number: 0004188661
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 07/11/2022
• Supplement Dates Manufacturer Received: 05/08/2022
• Supplement Dates FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention