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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-01185-002
Device Problem Defective Alarm (1014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/15/2022
Event Type  malfunction  
Manufacturer Narrative
Ventec will perform an evaluation of the device.A follow-up report will be submitted when the investigation is complete as defined by 21 cfr 803.56.
 
Event Description
It was reported to ventec that the device's alarms for breaths per minuite (bpm) and exhaled tidal volume (vte) were not working.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
2603 s goyer rd
kokomo IN 46902
Manufacturer Contact
atul sinha
22002 26th ave se
bothell, WA 98021
2067612204
MDR Report Key13727231
MDR Text Key287009539
Report Number3013095415-2022-00207
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 Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/15/2022
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-01185-002
Device Catalogue NumberPRT-01185-002
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/15/2022
Initial Date FDA Received03/10/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/23/2020
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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