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

Model Number	PRT-00490-100
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for an investigation.The reported event of failure to ventilate was confirmed.The investigation determined that an electrical component failed on the motherboard printed circuit board (pcb), which caused the device to fail to ventilate.The pcb was replaced and the device now ventilates.
Event or Problem Description
It was reported that the device failed to ventilate.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: 9578718
• Report Number: 3013095415-2020-00005
• Device Sequence Number: 2901457
• Product Code: CBK
• UDI-Device Identifier: 00855573007204
• UDI-Public: 0100855573007204
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2019

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-00490-100
• Device Catalogue Number: PRT-00490-100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 05/18/2021
• 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