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

Model Number AVEA

Device Problems Mechanical Problem (1384); Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2018

Event Type  Injury  

Manufacturer Narrative

The hospital biomed reported evaluating the device pressure transducer data, which displayed a drift of 75 a/d counts and decided to replace the gas delivery engine (gde) component.The customer reported the suspect gde component is available for analysis and a return good authorization (rga) has been issued.At this time, vyaire medical has not received the suspect gde 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 "circuit occlusion" alarm, while in use on this ventilator device.The customer reported that there was no patient harm associated with this event.

Manufacturer Narrative

Results of investigation: the vyaire failure analysis laboratory received the suspect gas delivery engine (gde) for investigation.The physical inspection found no anomalies with the gde.The investigation did duplicate the customer event during the performance and manufacture testing.The alarm conditions and device behavior has been identified with a railed expiratory pressure transducer component on the transducer communication alarm (tca) assembly within the gde.The root cause is associated with a material issue of the expiratory pressure transducer.The tca assembly will be held for trending and internally investigated within vyaire.

• Brand Name: AVEA VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7276902
• MDR Text Key: 100271534
• Report Number: 2021710-2018-07419
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103211
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVEA
• Device Catalogue Number: 17310-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2008
• 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
• Patient Outcome(s): Required Intervention