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

Model Number MICROBLENDER,W/2'/3' H,H/L,HFOV

Device Problem Protective Measures Problem (3015)

Patient Problem No Information (3190)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

Vyaire file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.At this time, the suspect device has not been returned for evaluation.Therefore, no root cause could be determined yet.

Event Description

The customer reported that the blender experienced gas differential alarm.The blender was used at 50 to 55 lpm.It started alarming at about 35 to 40 psi.It is the same alarm if one of the gas sources is low or the difference in pressure is 20 psi or greater.At this time, there is no information about patient involvement.

Manufacturer Narrative

Results of investigation: a field service representative is able to verify the customer's reported issue.Defective seat,proportioning,rear,hf mblndr (p/n: 03855) and valve,check,dckbl black (p/n: 03895).The defective parts (p/n: 03855 and p/n: 03895) have been removed and will be held in the fa lab for 90 days in case further investigation is needed.Microblender,w/2'/3' h,h/l,hfov (p/n: 10273 s/n: (b)(6)) will be returned to factory service.Fa lab recommendation is to install a new rear seat (p/n: 03855) and duckbill (p/n: 03895), rework to current configuration, recalibrate, retest per specifications, return to customer.

• 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
• MDR Report Key: 10394140
• MDR Text Key: 202514193
• Report Number: 2021710-2020-12328
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 10846446002317
• UDI-Public: (01)10846446002317
• 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: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MICROBLENDER,W/2'/3' H,H/L,HFOV
• Device Catalogue Number: 10723
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1