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

Model Number V60

Device Problems Device Displays Incorrect Message (2591); Operating System Becomes Nonfunctional (2996)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 03feb2021.

Event Description

The customer called into technical support (ts) reporting that the device¿s touchscreen froze and alarmed.The customer reported there was no patient involvement at the time the issue was discovered.

Manufacturer Narrative

G4:05mar2021.B4:08mar2021.H11:g5:k102985.H10: the customer evaluated the device with the remote service engineer (rse) assistance and could not confirm the reported issue as it could not be replicated.The customer had reported that the device was alarming various alerts, and none of the settings could be set or the alarms silenced.The customer ended up removing the battery on the unit to power down.The battery was then reconnected, and the unit was now working, including the touchscreen.The customer is now requesting assistance in carrying out the performance verification testing to ensure the vent is working correctly.The touchscreen has been checked, and its responsiveness in the service mode, and it reacts as it should.The rse recommended as a precaution replacing the navigation ring and bezel due to a device's report issue of being unresponsive.It was also observed that the touchscreen had surface chips and the rear bezel, end cap, top cover cracked.The reported problem could not be replicated by the customer.The rse provided parts id's for the navigation ring and bezel as a precaution to insure the problem is resolved.Parts were also ordered for the damaged parts for the customer to replace.The device passed required performance verification tests per philips standards.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

G4:17apr2021.B4:20apr2021.The field service engineer (fse) was dispatched to the customer site for additional evaluation.The fse determined that the unit being unresponsive was due to the navigation ring, and so the front bezel required replacement.During the evaluation, the fse also found that the rear bezel, end cap, and top cover were cracked, and the touchscreen had surface chips.The fse indicated that the physical damage did not affect the functionality of the touchscreen.Touchscreen functionality was corroborated by the customer in the initial call when they reported that after forcing the unit to shut down by removing the battery, the unit was turned back on in service mode and confirmed that the screen was then working.The customer tested the touchscreen on the diagnostic screen and confirmed that it reacted as expected.The fse replaced the front bezel to resolve the navigation ring failure.A remote service engineer (rse) followed up with the customer and provided the part information for the plastic enclosure parts and the touchscreen for the customer to complete the replacements.The customer confirmed that only the top cover was successfully replaced and indicated that they could not identify any defects with the rear bezel or end cap or any surface damage to the screen, so these parts were not replaced.The customer confirmed that the unit passed performance verification testing (pvt) and has been returned to clinical service without further issues.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: 11281136
• MDR Text Key: 242345213
• Report Number: 2031642-2021-00427
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838009851
• UDI-Public: (01)00884838009851
• 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: 01/07/2021

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: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053614
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 01/07/2021; 01/07/2021
• Supplement Dates FDA Received: 03/08/2021; 04/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2015
• 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