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

Model Number V60

Device Problem Display or Visual Feedback Problem (1184)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 11sep2020.

Event Description

It was reported to philips that the device's screen was dim.The device was not in use at the time of the event.There was no report of patient or user harm.The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The customer requested the part information for a replacement ui assembly.

Manufacturer Narrative

G4: 29sep2020.B4: 29sep2020.This issue was noted during service with the biomed.The device was evaluated by the customer (biomed) with assistance from a philips remote service engineer (rse).The customer requested the part information for a replacement ui assembly.The customer ordered and replaced the ui assembly and upgraded the software for the display to resolve the issue.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

G4:09feb2021; b4:11feb2021.The user interface assembly (assy, user interface, english).Visual inspection revealed no anomalies.A failure investigation (fi) technician installed returned ui assembly into a fi ventilator to duplicate the reported issue.During the unit testing the ui assembly was installed in the fi test ventilator to check for alarms and errors, and turn off unit using touch screen.The returned ui assembly was tested and in examination of the lcd panel, it was found that the wires connecting the backlight inverter to the display were discolored due to high temperature.The customer complaint was verified.The dim display was caused by failure of the lcd panel.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: 10523332
• MDR Text Key: 207721420
• Report Number: 2031642-2020-03230
• 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
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• 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: 12/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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