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

Model Number V60

Device Problems Image Display Error/Artifact (1304); 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) 2021.Date of report: 02mar2021.

Event Description

It was reported to philips that the screen was flickering and was not responsive.The device was not in clinical 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).

Manufacturer Narrative

G4: 07apr2021, b4: 30apr2021.Additional information was received from the hospital's biomed indicating that the unit's touchscreen was functioning and allowed settings to be changed, however, when the navigation ring was attempted to be used, the values would fluctuate and jump around preventing the user from setting the proper values.The biomed confirmed that the erratic values were not accepting any changes without the user's input.The biomed also verified that only the front bezel requires replacement and the part was successfully ordered to complete the repair.No part was received.Previous investigations have shown that liquid ingress due to the variability of the assembly process is known to cause a navigation ring failure.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

G4:30mar2021 b4:(b)(6) 2021 the device was evaluated by the hospital's biomed with assistance from a philips remote service engineer (rse).The biomed indicated that settings would flicker while setting and requested part id to complete the replacement themselves.The rse provided part information to replace the navigation ring and also the touchscreen in case it was needed.Multiple good faith efforts were made to obtain information regarding context of use, device evaluation, repair, and operational status with no response from the reporter and therefore cannot be determined.It is unknown if any parts or repair has been conducted.If additional information is later obtained, a supplemental 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.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11400930
• MDR Text Key: 242638206
• Report Number: 2031642-2021-00793
• 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: 02/02/2021

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: 02/02/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 02/02/2021; 02/02/2021
• Supplement Dates FDA Received: 04/06/2021; 04/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2012
• 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