MAUDE Adverse Event Report: VENTEC LIFE SYSTEMS, INC VOCSN; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number PRT-00797-000

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2023

Event Type  malfunction  

Manufacturer Narrative

The patient circuit was not returned to ventec for an evaluation.The cause for the reported issue could not be conclusively determined.Not returned to manufacturer.

Event Description

It was reported to ventec that a patient circuit (adult, passive, heated, with oxygen) broke near the exhalation valve during patient use.There was patient involvement associated with the reported event, however, there were no reports of patient harm as a result of the reported issue.No further details about the patient or the event were provided.Additionally, the initial reporter did not provide the vocsn serial number, or the lot code of the broken patient circuit.As result, section d4 (serial number, lot codes and udi number) are "unknown", and section h4 (device manufacturing date) shall be left blank.Section d4 model number and catalog number reflects the information known about the patient circuit.

• 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: mike kubany ; 22002 26th ave se; bothell, WA 98021 ; 4256861765
• MDR Report Key: 17075981
• MDR Text Key: 316887090
• Report Number: 3013095415-2023-00357
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRT-00797-000
• Device Catalogue Number: PRT-00797-000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 57 KG