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

Model Number V60

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 30oct2020.

Event Description

The customer reported a failure in the navigation ring.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: 18nov2020.B4: 19nov2020.The manufacturer¿s international service technician could not confirm the reported issue.A failure in the navigation ring was unable to be confirmed.The manufacturer¿s international service technician replaced the front bezel preventively 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

G4:20feb2021.B4:04mar2021.H11:g5:k102985.H10: the front bezel was returned to failure investigation for testing and evaluation.All test passed.The returned user interface (ui) front bezel assembly was tested with no functional failures being identified.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: 10766678
• MDR Text Key: 215329544
• Report Number: 2031642-2020-03996
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• 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: 12/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2019
• 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