MAUDE Adverse Event Report: VYAIRE MEDICAL VELA; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number VELA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information received from the customer will be included in a follow-up report.The customer reported the suspect main printed circuit board (pcb) component is available for analysis and a return good authorization (rga) has been issued.At this time, vyaire medical has not received the suspect main pcb component for evaluation.In the event that the device is received for evaluation or additional information is received, a follow-up report will be submitted.

Event Description

The customer reported an unresolved transducer failure on this vela ventilator device.The customer evaluated the device and determined the most likely cause of the failure was the main printed circuit board (pcb).The customer stated no patient involvement with this event.

Manufacturer Narrative

Result of investigation: the vyaire failure analysis group received the suspect main printed circuit board (pcb) for investigation.The fa group performed a visual inspection and found no anomalies.The fa engineer installed the main pcb into a test device and cycle the device on, which duplicated the reported alarm behavior.The event log was reviewed, which found multiple "xdcr" alarm errors.The calibrations were performed on the transducers and passed successfully.The combination of xdcr faults at power-up with the auto-zero indicates that the auto-zero solenoids can be slow to respond.This slow solenoids can intermittently result in a bad auto-zero calibration at power-up and operational auto-zero checks.At this time, the reported event was duplicated and the component root cause is associated with a supplier manufacturing process and design of sub components of this main pcb.This issue has been addressed in capa (b)(4).

• Brand Name: VELA
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; palm springs CA 92262
• Manufacturer Contact: mindy faber ; 26125 north riverwoods blvd; mettawa, IL 60045 ; 8727570116
• MDR Report Key: 7650472
• MDR Text Key: 112740010
• Report Number: 2021710-2018-09030
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K093094
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VELA
• Device Catalogue Number: 16532-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1