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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-01201-000
Device Problem Inaccurate Delivery (2339)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2023
Event Type  malfunction  
Event Description
It was reported to ventec by an authorized third party service provider (asp) that the device's inspiratory tidal volume (vti) levels were low.There were no reports of patient involvement associated with the reported event.
 
Manufacturer Narrative
The authorized third party service provider (asp) will further evaluate and repair the device.A follow-up report will be submitted when the investigation is complete as defined by 21 cfr 803.56.
 
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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
2603 s goyer rd
kokomo IN 46902
Manufacturer Contact
mike kubany
22002 26th ave se
bothell, WA 98021
4256861765
MDR Report Key16549562
MDR Text Key311485343
Report Number3013095415-2023-00194
Device Sequence Number1
Product Code CBK
UDI-Device Identifier00855573007945
UDI-Public0100855573007945
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 Other
Reporter Occupation 505
Type of Report Initial
Report Date 02/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPRT-01201-000
Device Catalogue NumberPRT-01201-000
Was Device Available for Evaluation? No
Date Manufacturer Received02/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/17/2020
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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