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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 Problem Calibration Problem (2890)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2021
Event Type  malfunction  
Manufacturer Narrative
A vyaire field service representative (fsr) went onsite and evaluated the ventilator.Verified correct setup & calibration of blender.Reviewed setup and calibrate with staff on site.Verified operation of power supply, pressure xdcr/transducer, and ddi/device driver's interface calibration.Ran patient circuit calibration and performance check.All tests passed required criteria.Unit meets factory specifications.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 3100a unit connected and running.However, the blender was not connected correctly and our patient got 100% oxygen regardless of the blender being set on 21%.This ended up causing very high pa02(partial oxygen pressure) results and took a lot of troubleshooting to correct.The reporter confirmed that there is a patient involvement associated on this event.However, no harm noted.
 
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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
peter sparacio
26125 n. riverwoods blvd.
mettawa, IL 60045
8333273284
MDR Report Key11691020
MDR Text Key246212817
Report Number2021710-2021-13737
Device Sequence Number1
Product Code LSZ
UDI-Device Identifier10846446003079
UDI-Public(01)10846446003079(11)20201223
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 03/24/2021
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
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/24/2021
Initial Date FDA Received04/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/23/2020
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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