MAUDE Adverse Event Report: VYAIRE MEDICAL 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 Bradycardia (1751)

Event Date 02/09/2022

Event Type  Injury  

Event Description

The customer reported that the boxed pat circuit assy,3100a,fltrd,850l is extremely pliable/bendy which has implications with the flow on the oscillator and often stops the oscillator.It is often associated with the tubing that is connected to the humidifier.Tubing needed to be put back on/replaced and secured with a tape.It happened during use, and the patient became bradycardic and had to be manually ventilated.Also, lung derecruitment occurred.

Manufacturer Narrative

The customer sent a picture for evaluation however, the reported issue if the tube or component were soft or malleable was not confirmed.A sample is needed to perform a better investigation looking for any issue with the resin.Therefore the root cause was not determined.In addition pfmea 10a was reviewed and we have controls for this kind of issue.The issue occurred with three patients.Please refer to (b)(4) and (b)(4) for the other two patients.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: BOXED PAT CIRCUIT ASSY,3100A,FLTRD,850L
• Type of Device: VENTILATOR, HIGH FREQUENCY
• 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: 13779839
• MDR Text Key: 287286608
• Report Number: 8030673-2022-00234
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 50190752159820
• UDI-Public: (01)50190752159820(10)0004179629
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• 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: 0004179629
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/15/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention