MAUDE Adverse Event Report: VYAIRE MEDICAL INC. PALMTOP VENTILATOR, MODELS PTV-8, PTV-10; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number REVEL

Device Problem Mechanical Problem (1384)

Patient Problem Death (1802)

Event Date 11/25/2019

Event Type  Death  

Manufacturer Narrative

Vyaire medical was not able to duplicate the reported issue during testing and evaluation.The ventilator passed 185 hours of extended testing without any unusual alarm or error condition.The ventilator also passed the initial final test and initial alarm volume test with no issue.The ventilator was opened up and inspected, there were no anomalies noted.A review of the event trace log revealed a hardware fault 21 alarm condition was last logged on (b)(6) 2019 23:34:16.624 (gmt).Vyaire medical replaced the hybrid board as a precaution to address hardware fault issue.

Event Description

It was reported to vyaire medical that the ventilator alarmed "hardware fault 21" while in use on a patient.The patient was placed on another ventilator and passed away an hour later.

• Brand Name: PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 17400 medina road suite 100; plymouth 55447
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 9512129
• MDR Text Key: 172463680
• Report Number: 2031702-2019-03373
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REVEL
• Device Catalogue Number: 19260-001-99
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2013
• 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): Death