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

Model Number 19260-001

Device Problem No Pressure (2994)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Results of investigation: the vyaire factory service dept.Received the revel ventilator and performed an investigation.The ventilator was powered on and no flow was being produced and no breaths were being delivered.Bench testing revealed the blower module was malfunctioning.The reported problem was confirmed.Inspection of the blower module revealed the component q4 was burned.The device was repaired, passed final testing and was returned to the customer.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported to vyaire medical that the revel ventilator was not producing any pressure or air during pretesting.The customer advised there was no patient involvement.

• Brand Name: PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 17400 medina road suite 100; minneapolis MN 55447
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8333273284
• MDR Report Key: 10763074
• MDR Text Key: 213902937
• Report Number: 2031702-2020-03720
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00845873000029
• UDI-Public: (01)00845873000029(11)20180108
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 19260-001
• Device Catalogue Number: 19260-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2018
• 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