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

Model Number REVEL

Device Problem Defective Device (2588)

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

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

H3:02-the suspect device was returned and evaluation is anticipated but not yet begun.Once a final investigation is complete, a follow-up report will be submitted.

Event Description

It was reported to vyaire medical that blower demand exceeded alarm error during use on a patient on the revel ventilator.The customer reported there was no patient harm associated with the reported event.

Manufacturer Narrative

Results of investigation: vyaire medical received the device for evaluation.Visual inspection of the uut (unit under test) found no signs of damage or misuse.A review of the event trace indicates that the blower demand exceeded alarm conditions are preceded by alarm conditions that indicate the presence of a significant patient circuit leak.These preceding alarm conditions include low tidal volume expire alarm, low peak alarm, low positive end expiratory pressure alarm, and high breath rate alarm which repeatedly trigger then recover along with the blower demand exceeded alarm condition.The presence of a patient circuit leak over the 30lpm leak compensation capabilities of the palm top ventilator can result in continuous peak blower operation while the ventilator attempts to meet the breath requirement settings of the patient.Unable to duplicate the reported complaint but verified through event trace.Uut was functional with no issues or faults.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• 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.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18455752
• MDR Text Key: 332411607
• Report Number: 2021710-2024-18623
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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