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

Model Number 3100A

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 08/14/2020

Event Type  malfunction  

Manufacturer Narrative

A vyaire field service representative (fsr) went onsite and was able to verify reported issue.Map reading zero was found due to loose connection at connector.The loose connection was repaired.

Event Description

The customer reported to vyaire medical that the mean airway pressure (map) of 3100a displays a constant 0.00 reading and will not display anything, no matter what the settings are.At this time, there is no information about patient involvement on the reported event.

• Brand Name: 3100A VENTILATOR
• 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: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, il ; 3273284
• MDR Report Key: 10498038
• MDR Text Key: 206126314
• Report Number: 2021710-2020-12516
• 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: 08/14/2020

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: 3100A
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2020
• Initial Date FDA Received: 09/05/2020
• 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