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

Model Number 3100 A

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

Results of investigation: this unit was serviced by a vyaire medical authorized service technician.The service technician examined the unit internally and discovered the speaker wire was disconnected.The service technician reconnected the wire, plugged the unit in, and removed ac power.The service technician got an audible "power fail" alarm.The service technician was able to correct the reported issue.

Event Description

It was reported to vyaire medical that while in use on a patient, the map (mean airway pressure) alarm was not audibly working.The map drifted and the alarm light came on, but no audible alarm occurred.The customer stated that the alarms were set appropriately, but ventilator did not sound when alarms reached the limit.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): VYAIRE MEDICAL, INC; 1100 bird center dr.; palm springs CA 92262
• Manufacturer Contact: mindy faber ; 26125 north riverwoods blvd; mettawa, IL 60045
• MDR Report Key: 7742628
• MDR Text Key: 115801806
• Report Number: 2021710-2018-08023
• Device Sequence Number: 1
• Product Code: LSZ
• 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: 08/02/2018

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 Model Number: 3100 A
• Device Catalogue Number: PS-768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2018
• Initial Date FDA Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2010
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention