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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 A
Device Problem Calibration Problem (2890)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A vyaire field service representative(fsr) evaluated the device onsite discovered that the control cap diaphragm needs reset.The control cap diaphragm was reseated and the voltages on the dc (direct current) power supply were verified.The airway pressure transducer and ddi (dynamic displacement indicator) calibration were completed.Alarm function test was performed.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 that the 3100a ventilator is intermittently failing circuit calibration.It will fail then pass with the same circuit.The customer confirmed that there was no patient involvement associated with the reported event.
 
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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 Key11629467
MDR Text Key244264145
Report Number2021710-2021-13653
Device Sequence Number1
Product Code LSZ
UDI-Device Identifier10846446005394
UDI-Public(01)10846446005394(11)20180917
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 03/12/2021
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 Number3100 A
Device Catalogue Number768901
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/12/2021
Initial Date FDA Received04/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2018
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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