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

Model Number V60

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 27oct2020.

Event Description

It was reported to philips that the device had an error message that the blower was hot.The device was not in use at the time of the event.There was no report of patient or user harm.

Manufacturer Narrative

G4: 03nov2020 b4: (b)(6) 2020 the customer stated this issue occurred during testing.The philips field service engineer (fse) confirmed the reported issue.The fse replaced the blower assembly to resolve the issue and confirmed the device fully meets specification and was 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

G4:23jan2021.B4:28jan2021.The blower assembly was returned for failure evaluation.Visual inspection of the blower assembly outer surface revealed no evidence of damage or contamination.The blower assembly end cap was removed and a visual inspection of the impellers and surroundings did not reveal any signs of rubbing, damage, or contamination.A failure investigation (fi) technician installed the returned blower assembly into a fi ventilator to duplicate the reported issue.During the unit testing the blower assembly was installed in the fi test ventilator and booted in normal operation mode to verify the ventilator remains operational with no errors detected.The returned blower assembly passed all testing.A high blower temperature alarm (1122 error code) could not be duplicated.There were no faults found with the blower assembly.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: 10742664
• MDR Text Key: 214759306
• Report Number: 2031642-2020-03869
• 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: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• 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: 12/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2013
• 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