MAUDE Adverse Event Report: V60 VENTILATOR; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Model Number V60

Device Problem Device Sensing Problem (2917)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 18sep2020.

Event Description

The customer reported unit does not recognize the blood pressure values.The device was reported to be in clinical use at the time the reported issue was discovered; however, there was no reported patient or user harm.

Manufacturer Narrative

G4:30dec2020.B4:31dec2020.The field service engineer (fse) indicated error code consistent with carbon dioxide (co2) leak and rebreathing and indicated the flow graph appears inverted when clicking and no volume graph appears.The fse state the unit correctly passes the "pressure delivery accuracy" test but not the "flow delivery accuracy" test, giving oscillating values without any control.Flow sensor block failure, requires gas delivery system (gds) replacement.The fse replaced the gds to resolve the reported issue.A gas delivery system (gds) was returned for analysis.Visual inspection of the returned gds revealed no anomalies.An investigation was performed and the customer complaint verified.Root cause was failure of airflow sensor, caused by u1 drifting out of calibration.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

G4: 13nov2020 b4: (b)(6) 2020 the customer accepted the quote to replace the gas delivery system (gds).Pending for repair details.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 10557323
• MDR Text Key: 208329459
• Report Number: 2031642-2020-03354
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK AND HUMIDIFIER