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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 3100 B
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
 
Event Description
The customer reported to vyaire medical that the 3100b ventilator will not pressurize.At this time, there is no information regarding patient involvement associated with the reported event.
 
Manufacturer Narrative
Device evaluation: d10, g4, g7, h2, h3, h6 and h10.A vyaire field service representative (fsr) went onsite and evaluated the ventilator.Performed 6 year & 3k pm on unit which took care of this issue.Product has been verified & tested ok.
 
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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
MDR Report Key10743861
MDR Text Key213435814
Report Number2021710-2020-12753
Device Sequence Number1
Product Code LSZ
UDI-Device Identifier10846446003468
UDI-Public(01)10846446003468(11)20090911
Combination Product (y/n)N
PMA/PMN Number
P890057
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3100 B
Device Catalogue Number770155-RFB
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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