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

Model Number REVEL

Device Problems Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Results of investigation: vyaire medical was not able to duplicate the customer¿s reported issue during testing and evaluation.The ventilator was tested with a known good ac adapter connected and the ventilator would not boot up.The ventilator powered on, however, it would go into a constant reset condition.Bench testing revealed the o2 blender was not communicating with ventilator.The o2 blender was missing the boot up application.Vyaire medical replaced the o2 blender.

Event Description

It was reported to vyaire medical that when you insert the transport battery, the ventilator starts alarming "inop".While in service, the reported issue was able to be duplicated and the ventilator went into a constant reset condition.

• Brand Name: PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
• 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; 17400 medina road suite 100; plymouth MN 55447
• Manufacturer Contact: kristin graf ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 7154742
• MDR Text Key: 96056379
• Report Number: 2031702-2017-02043
• 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: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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