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U.S. Department of Health and Human Services

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

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VYAIRE MEDICAL INC. 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY Back to Search Results
Model Number 3100A
Device Problem Calibration Problem (2890)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2021
Event Type  malfunction  
Manufacturer Narrative
A vyaire field service representative (fsr) went onsite and evaluated the ventilator.It was seen that the circuit just had ton of water in it.The fsr replaced the circuit and calibrated the unit also replaced the unit's battery and rear filters.The 3100a ventilator unit runs perfectly now.
 
Event Description
The customer reported to vyaire medical that the 3100a ventilator was having circuit issues with passing the initial performance check.The reporter confirmed that there is no patient involvement associated on this event.
 
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Brand Name
3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
Type of Device
VENTILATOR, HIGH FREQUENCY
Manufacturer (Section D)
VYAIRE MEDICAL INC.
26125 n. riverwoods blvd.
mettawa IL 60045
Manufacturer (Section G)
VYAIRE MEDICAL INC.
1100 bird center drive
palm springs CA 92262
Manufacturer Contact
erika bonilla
510 technology dr
irvine, IL 92618
MDR Report Key12089575
MDR Text Key259370788
Report Number2021710-2021-14099
Device Sequence Number1
Product Code LSZ
UDI-Device Identifier10846446003079
UDI-Public(01)10846446003079(11)20150604
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 faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/02/2021
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-RNT
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/02/2021
Initial Date FDA Received06/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/04/2015
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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