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

Model Number V60

Device Problem Failure to Read Input Signal (1581)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 16oct2020.

Event Description

It was reported that the customer found the touchscreen to not responding properly.The device was being set up for use, however there was no patient harm.The reported the issue was confirmed by operational check performed by the field service engineer (fse).Since the issue was not resolved by calibrating the touchscreen, the touchscreen needs to be replaced.

Manufacturer Narrative

G4:(b)(6)2021 b4:20jan2021 failure analysis on the returned touchscreen assembly shows that the touchscreen was tested, the resistance measurement fail.Customer complaint was verified.Root cause is failure of touchscreen assembly.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: 10693771
• MDR Text Key: 214800186
• Report Number: 2031642-2020-03753
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)00884838033832
• 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
• Report Date: 09/27/2020

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
• Device Catalogue Number: 1076709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 09/27/2020
• Supplement Dates FDA Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2018
• 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