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 Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported navigation ring failure.The device was in clinical use at the time the issue was discovered.There was no patient or user harm reported.

Manufacturer Narrative

G4:28dec2020.B4:31dec2020.The customer reported navigation ring issue and the device generates noise.The customer disconnected it, and the problem disappeared.The remote service engineer (rse) confirmed the reported failure.The customer requested a quote for the front panel.The front panel includes the navigation ring.Multiple attempts were made to gather more information regarding the repair; however, attempts were unsuccessful.If additional information is received, an additional report will be submitted.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

G4:28dec2020.B4:29dec2020.Udi#: (b)(4).Patient code updated there was no patient involvement.This case is a "material only - which means that they just order the parts and the case was closed.There is no investigation concerning the case.After further investigation of this complaint, new information received deems this case to be non-reportable.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: 12jan2021.B4: 13jan2021.Additional information received that the device was not in clinical use when the issue was discovered.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: 10764572
• MDR Text Key: 215327265
• Report Number: 2031642-2020-03974
• 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: 10/15/2020

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
• Device Operator: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 10/15/2020; 10/15/2020; 10/15/2020
• Supplement Dates FDA Received: 12/29/2020; 12/31/2020; 01/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2017
• 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