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

Model Number V60

Device Problem Gas/Air Leak (2946)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 15oct2020.

Event Description

The customer reported low leak co2 rebreathing risk.The unit was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or the user.

Manufacturer Narrative

G4:25nov2020.B4:30nov2020.H11: h6: patient code updated.There was no patient involvement.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: 05nov2020.B4: 05nov2020.The service technician confirmed the reported issue.The service technician replaced the defective flow sensor to address the reported problem.The unit successfully passed the required performance verification test.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

G4:10mar2021.B4:18mar2021.The defective gas delivery system (gds) assembly was returned for failure investigation.Visual inspection revealed no anomalies.A failure investigation (fi) technician installed the gds assembly into a fi ventilator, booted unit in normal operation mode and checked for alarms and errors.During the unit testing, the fi technician identified a failure for the airflow sensor, caused by u1 drifting out of calibration.The determination could be made that the device failed to meet specifications.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: 10687615
• MDR Text Key: 213503341
• Report Number: 2031642-2020-03743
• 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,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2011
• 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.