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

Model Number V60

Device Problem Poor Quality Image (1408)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 05jun2020.

Event Description

The customer reported top screen dark.The unit was not in use and there was no patient or user harm.

Manufacturer Narrative

G4: 22jul2020.B4: 07aug2020.The field service engineer (fse) confirmed the reported failure.The fse identified the liquid crystal display (lcd) panel is defective.The (fse) also found the power switch overlay has a hole, and the bezel end cap is broken.The power cord retainer and two feet are missing.The (fse) replaced the (lcd) panel, (lcd) cable, user interface (ui) cable, user interface (ui) printed circuit board assembly (pcba), and (lcd) screws, (lcd tray) to resolve the reported issue.Still pending more info.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: 19aug2020 b4: (b)(6) 2020 the field service engineer (fse) replaced the liquid crystal display (lcd) panel, lcd cable, user interface (ui) cable, ui printed circuit board assembly (pcba), and lcd screws, lcd tray to resolve the reported issue.The unit was tested and it returned to service.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

G4:18mar2021.B4:24mar2021.The liquid crystal display (lcd) was returned to manufacturer to failure investigation (fi) for analysis.The burn out cold cathode fluorescent lamp (ccfl) backlight causes the dim display.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: 10125663
• MDR Text Key: 194615952
• Report Number: 2031642-2020-01980
• 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: user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/18/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 05/18/2020; 05/18/2020; 05/18/2020
• Supplement Dates FDA Received: 08/07/2020; 08/20/2020; 03/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2009
• 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