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

Model Number REVEL

Device Problem Improper Flow or Infusion (2954)

Patient Problem Respiratory Failure (2484)

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

The vyaire failure analysis laboratory received the suspect component and performed a failure investigation on the unit.Loss of o2 alarms were found in the event trace.A good ac(alternating current) adapter, patient circuit, o2(oxygen)supply line and o2 sensor was connected.The unit was turned on and the o2 setting was changed from 21% to 60%.It passed 51.1 hours of extended testing, initial final test and initial alarm volume test.They were unable to duplicate the reported problem.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 that the revel ventilator was alarming low oxygent.The issue occurred during patient-use and the patient was manually ventilated via bag valve mask before being transferred to a different ventilator.The patient experienced respiratory failure and hemodynamic instability due to the event.

• 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: 10543886
• MDR Text Key: 207305372
• Report Number: 2031702-2020-03676
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00845873000029
• UDI-Public: (01)00845873000029(11)20140204
• Combination Product (y/n): Y
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: Yes
• 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: 08/04/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2014
• 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
• Patient Outcome(s): Required Intervention