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U.S. Department of Health and Human Services

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

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VYAIRE MEDICAL 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY Back to Search Results
Model Number 3100A
Device Problems Mechanical Problem (1384); No Pressure (2994)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2023
Event Type  malfunction  
Event Description
It was reported to vyaire medical that the 3100a ventilator will not pressurize.Furthermore, there was no patient involvement associated with the reported event.
 
Manufacturer Narrative
Vyaire medical file identification: (b)(4).H3: 81 other -at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device not returned yet.
 
Manufacturer Narrative
Results of investigation: vyaire medical field service representative (fsr) went on site to check and inspect the device.The root cause was determined due to loose bias flow.Checked unit and found tubing inside pneumatics that connects to the bias flow loose.As a resolution, vyaire ts was able to secured tubing and the unit pressurized.
 
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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 60045
Manufacturer (Section G)
VYAIRE MEDICAL INC.
1100 bird center drive
palm springs CA 92262
Manufacturer Contact
sandra valencia
510 technology drive
irvine, CA 92618
MDR Report Key18055693
MDR Text Key327166078
Report Number2021710-2023-18348
Device Sequence Number1
Product Code LSZ
UDI-Device Identifier10846446003079
UDI-Public(01)10846446003079
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P890057
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 11/02/2023
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 Number3100A
Device Catalogue Number768901
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/04/2023
Initial Date FDA Received11/02/2023
Supplement Dates Manufacturer Received04/17/2024
Supplement Dates FDA Received05/07/2024
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 Number1
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