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

Model Number 3100 A

Device Problem Defective Alarm (1014)

Patient Problem No Patient Involvement (2645)

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Any additional information provided by the customer will be included in a follow up report.The healthcare facility attempted to replace the alarm board on this device.However, the reported issue was not resolved.At this time, vyaire has not received the suspect device/component for evaluation.

Event Description

It was reported to vyaire medical that the 3100 a unit power failure alarm will not alarm.The customer confirmed that there was no patient involvement associated with the reported issue.

Manufacturer Narrative

The vyaire field service representative (fsr) was able to replicate the reported problem.The field service technician was able to resolve the issue by re-seating the 9 volt battery and all alarm cables and connectors.Performed pt calibration and performance check, all passed per 3100a ventilator label.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9145085
• MDR Text Key: 164392304
• Report Number: 2021710-2019-10855
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(11)20040501
• Combination Product (y/n): N
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

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: 768901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 10/09/2019
• Supplement Dates FDA Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1