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

Model Number	PRT-00900-001
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a ventilator was being set up and did not pass the pre-use test.It was noted that the unit was not ventilating.There was no patient involvement.
Event or Problem Description
It was reported that a ventilator was being set up and did not pass the pre-use test.It was noted that the unit was not ventilating.There was no patient involvement.
Additional Manufacturer Narrative
H9.After additional analysis by ventec, it has been determined that there is a potential risk to health associated with blower circuit failures resulting in unexpected shut downs and/or loss of ventilation.As a result of this investigation, ventec has initiated a field corrective action (reference corrections and removals number 3013095415-4/12/2021-001-r).

• Brand Name: VOCSN
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VENTEC LIFE SYSTEMS, INC; 22002 26th ave se; bothell WA 98021
• MDR Report Key: 8313041
• Report Number: 3013095415-2019-00002
• Device Sequence Number: 14004143
• Product Code: CBK
• UDI-Device Identifier: 00855573007433
• UDI-Public: (01)00855573007433(11)180516
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K162877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2019

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
• Operator of Device: Health Professional
• Device Model Number: PRT-00900-001
• Device Catalogue Number: PRT-00900-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 12/20/2018; 04/19/2021
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 04/17/2019; 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3013095415-4/12/2021-001
• Patient Sequence Number: 1