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

Model Number 3100 A

Device Problems Mechanical Problem (1384); Failure to Align (2522)

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

Event Date 10/11/2023

Event Type  malfunction  

Manufacturer Narrative

H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.

Event Description

It was reported to vyaire medical that the customer can´t center the piston driver of 3100a ventilator.This happened during patient use.There was no information of patient harm reported with this event.

Manufacturer Narrative

Results of investigation: vyaire medical was not able to verify the customer complaint.The suspect device was not returned for investigation.However, the distributor went onsite and was able to center the piston, but it was not going any further to the left.According to the end user, it should go further.Vyaire requested for serial number/part number at the back of the panel or any pictures.It was also advised to check the ddi (dynamic displacement indicator) calibration and/or the driver power module calibration.Additionally, the distributor has indicated that the suspect device was calibrated as per instructions.Unit is now working correctly.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• 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 ; 7607787281
• MDR Report Key: 18088592
• MDR Text Key: 327670597
• Report Number: 2021710-2023-18375
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

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: 768909
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 02/19/2024
• Supplement Dates FDA Received: 04/30/2024
• 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