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
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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)
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10394140
• Report Number: 2021710-2020-12328
• Device Sequence Number: 3447161
• Product Code: LSZ
• UDI-Device Identifier: 10846446002317
• UDI-Public: (01)10846446002317
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P890057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

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
• Operator of Device: Health Professional
• Device Model Number: MICROBLENDER,W/2'/3' H,H/L,HFOV
• Device Catalogue Number: 10723
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 09/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1