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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-00490-001
Device Problem Defective Alarm (1014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2021
Event Type  malfunction  
Manufacturer Narrative
The device was evaluated by ventec where the reported issue of the device's alarm not functioning was confirmed.Ventec replaced the device's control board to resolve the reported issue.Proper device operation was then observed through functional and performance testing.The investigation determined that the root cause of the reported issue was the control board.
 
Event Description
It was reported that the device needed service.Upon evaluation of the device, ventec observed that its audible alarm was not functioning when alarm conditions were triggered.There was no patient involvement associated with the reported event.
 
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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
atul sinha
22002 26th ave se
bothell, WA 98021
2067612204
MDR Report Key13804599
MDR Text Key287561673
Report Number3013095415-2022-00313
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 Other
Type of Report Initial
Report Date 02/17/2022
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 NumberPRT-00490-001
Device Catalogue NumberPRT-00490-001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2021
Initial Date Manufacturer Received 02/17/2022
Initial Date FDA Received03/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2020
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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