MAUDE Adverse Event Report: VYAIRE MEDICAL 3100A HIGH FREQUENCY OSCULATING VENTILATOR; VENTILATOR, HIGH FREQUENCY

Catalog Number 768901

Device Problem Output below Specifications (3004)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/17/2021

Event Type  Injury  

Manufacturer Narrative

Vyaire complaint number: (b)(4).Vyaire medical's field service representative (fsr) went on-site to evaluate the 3100a ventilator.The fsr found both power knob and adjustment knob were loss.The issue was corrected by adjusting the knobs to the correct position.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 adjustment knob is not working well on the 3100a ventilator; it doesn't adjust the map.The problem occurred when the equipment was on a patient.The therapist (who didn't set up the equipment), noticed an odd sound and the patient was decompensating.

• Brand Name: 3100A HIGH FREQUENCY OSCULATING VENTILATOR
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• 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: 13771443
• MDR Text Key: 287202612
• Report Number: 2021710-2022-15749
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(11)19990114
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2021
• Initial Date FDA Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/1999
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1