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

Model Number 3100A

Device Problem Alarm Not Visible (1022)

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

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

Vyaire file identification: (b)(4).A vyaire field service representative(fsr) evaluated the device onsite and observed that there are fluctuations in the map (mean airway pressure) not holding steady at the set value.The map was set to 13.2 cm h20 but the max paw (airway pressure) alarm would go off when it is set for a max paw of 16 cmh20.The thumbheel and switches were replaced and the map is now steady and the alarm limits go off when the map goes above the setting.The unit passed the performance test and the calibration test passed after adjustments to the pneumatics.Ddi (dynamic displacement indicator) calibrations were performed to make adjustments to centering of the piston and voltages coming out of the psu (power supply unit)were checked and all checked out okay.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

It is reported to vyaire medical that the 3100a ventilator that the device did not alarm when set to min paw at 14 cm.The customer confirmed there was no patient involvement.

• 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: 12542331
• MDR Text Key: 273679622
• Report Number: 2021710-2021-14633
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(11)20090827
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3100A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2009
• 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