MAUDE Adverse Event Report: VYAIRE MEDICAL INC. 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number 3100 A

Device Problem Pressure Problem (3012)

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

Event Date 09/16/2022

Event Type  malfunction  

Event Description

It was reported to vyaire medical that the 3100a ventilator mean airway pressure (map) is jumping while adjusting pr3.At this time there was no information of patient involvement reported with this event.

Manufacturer Narrative

Vyaire medical file identification: (b)(4).A vyaire field service representative(fsr) evaluated the device onsite and found that the pr6 and fv1 numbers are high and out of specification.The pr2 was also lo.The fsr calibrated the pneumatics and all pressure regulators are within specification.The fv1 was also calibrated within specification/ the fsr also performed calibrations on the airway pressure monitor and ddi (dynamic displacement indicator).2k preventive maintenance was completed and performance check was done.The unit passed all tests and runs accrording to oem (original equipment manufacturer) specifications.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15589278
• MDR Text Key: 301946613
• Report Number: 2021710-2022-16717
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446005554
• UDI-Public: (01)10846446005554(11)19980427
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• 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
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100 A
• Device Catalogue Number: 23689-201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/1998
• 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