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

Model Number V60

Device Problems Crack (1135); 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 this report: 28sep2020.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.

Event Description

The philips international field service engineer (fse) identified and reported that ventilator had a display issue and enclosure crack.The device was not in clinical use at the time the issue was discovered.There was no patient or user harm reported.

Manufacturer Narrative

G4: (b)(6) 2020 b4: 01oct2020 the philips field service engineer (fse) confirmed and duplicated the reported issue via operational check.Following the evaluation of the device, the fse replaced the user interface assembly and the top cover to resolve the issues.The unit was then functionally tested and successfully passed all specified tests.No other abnormality was observed.The determination could be made that the device failed to meet specifications as the defective user interface assembly and top cover required replacements to have the ventilator operating and meeting specifications.Additionally, the device was not being used for treatment when the reported event occurred, and no patient harm was reported.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: 30dec2020 b4: (b)(6) 2021.The customer returned user interface (ui) assembly visual inspection revealed no anomalies.A failure investigation (fi) technician installed the user interface (ui) assembly into a fi ventilator to duplicate the reported issue of display issue.The fi technician identified that the display issue was caused by a failure of the lcd (liquid crystal-display) 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: 10597670
• MDR Text Key: 209445487
• Report Number: 2031642-2020-03486
• 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: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• 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: 12/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2009
• 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