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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTEC LIFE SYSTEMS, INC VOCSN; VENTILATOR, CONTINUOUS, FACILITY USE
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VENTEC LIFE SYSTEMS, INC VOCSN; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number PRT-01185-000
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2024
Event Type  malfunction  
Event Description
It was reported that the device needed service.During the device's evaluation, ventec observed that it was displaying a patient circuit disconnect alarm.There was no patient involvement associated with the reported event.
 
Manufacturer Narrative
H6: the device was evaluated by ventec where the reported issue of it displaying a patient circuit disconnect alarm was confirmed.Ventec replaced the external flow module (efm) to resolve the reported issue.Proper device operation was then confirmed through functional and performance testing.The investigation determined that the cause of the reported issue was the efm.
 
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Brand Name
VOCSN
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
VENTEC LIFE SYSTEMS, INC
22002 26th ave se
bothell WA 98021
Manufacturer (Section G)
VENTEC LIFE SYSTEMS, INC
22002 26th ave se
bothell WA 98021
Manufacturer Contact
elizabeth gilbert
22002 26th ave se
bothell, WA 98021
4256861765
MDR Report Key18790569
MDR Text Key336541519
Report Number3013095415-2024-00185
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162877
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberPRT-01185-000
Device Catalogue NumberPRT-01185-000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2023
Date Manufacturer Received02/02/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/27/2023
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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