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

Model Number PRT-00900-100

Device Problems Defective Alarm (1014); Output Problem (3005)

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

Event Date 09/09/2022

Event Type  malfunction  

Event Description

It was reported to ventec that the device's alarm was not working as expected.The reporter advised that the mean airway pressure (map) alarm did not sound, even when the set value of 40cmh2o had been exceeded.There were no reports of patient involvement associated with the reported event.

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.

Manufacturer Narrative

Corrected information for supplemental medwatch 001 - section d9, device available for evaluation - date returned to manufacturer, of the initial medwatch report stated: blank.Section d9, device available for evaluation - date returned to manufacturer, of the initial medwatch report should have stated: 10/10/2022.New information for supplemental medwatch 001 - h6: the customer was expecting an alarm when the device's mean airway pressure (map) exceeded it's set value of 40cmh20.The vocsn map monitor displays the average pressure delivered throughout the breath period of the last eight breaths, but does not provide an alarm when the device exceeds the set value.Ventec performed an evaluation of the device where it was observed that its exhaled tidal volume (vte) levels were low.Ventec replaced the external flow module (efm) 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 observed low vte levels was the efm.Ventec determined that the device's alarm system function as intended.The ventec service team will reach out to the distributor to remind them that there is no map alarm.

Manufacturer Narrative

Corrected information for supplemental medwatch report -002 --.Section h10, manufacturer narrative, of supplemental medwatch report -001 stated that the new information for supplemental medwatch report 001 was as follows: h6: the customer was expecting an alarm when the device's mean airway pressure (map) exceeded it's set value of 40cmh20.The vocsn map monitor displays the average pressure delivered throughout the breath period of the last eight breaths, but does not provide an alarm when the device exceeds the set value.Ventec performed an evaluation of the device where it was observed that its exhaled tidal volume (vte) levels were low.Ventec replaced the external flow module (efm) 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 observed low vte levels was the efm.Ventec determined that the device's alarm system function as intended.The ventec service team will reach out to the distributor to remind them that there is no map alarm.Section h10, manufacturer narrative, of supplemental medwatch report -001 should have stated that the new information for supplemental medwatch report 001 was as follows: h6: the customer was expecting an alarm when the device's mean airway pressure (map) exceeded it's set value of 40cmh20.The vocsn map monitor displays the average pressure delivered throughout the breath period of the last eight breaths, but does not provide an alarm when the device exceeds the set value.Ventec performed an evaluation of the device where it was observed that its exhaled tidal volume (vte) levels were low.Ventec replaced the external flow module (efm) 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 observed low vte levels was the efm.Ventec determined that the device's alarm system function as intended.The ventec service team will reach out to the distributor to remind them that there is no map alarm.The investigation for this event was completed after conducting a retrospective review of service records and is considered to be a late mdr.

• 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: 15584144
• MDR Text Key: 302602848
• Report Number: 3013095415-2022-00812
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2022

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 Number: PRT-00900-100
• Device Catalogue Number: PRT-00900-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/16/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 01/13/2023; 01/13/2023
• Supplement Dates FDA Received: 01/13/2023; 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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