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

Model Number 3100 A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 12/23/2019

Event Type  Death  

Manufacturer Narrative

Vyaire medical complaint number: (b)(4).Any additional information provided by the customer will be included in a follow up report.At this time, vyaire has not received the suspect device/component for evaluation.

Event Description

It was reported to vyaire medical that on (b)(6) 2019 the 3100 a ventilator stopped working while connected to a patient.The customer understands that the ventilator became unplugged somehow, which resulted in significant brain damage to the patient.The patient passed away from her injuries on (b)(6) 2019.

• 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
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs, ca
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9950307
• MDR Text Key: 187271369
• Report Number: 2021710-2020-11712
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Death
• Patient Age: 4 MO