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

Model Number V60

Device Problems Nonstandard Device (1420); Self-Activation or Keying (1557); Inaudible or Unclear Audible Prompt/Feedback (2283)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 07oct2020.

Event Description

It was reported to philips by the biomed that the v60 was turning on and off on its own.The biomed reporting the v60 is turning itself off without any audible notification.The device was 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).The rse recommended ordering and replacing v60 ui assembly.The biomed called back to inquire if the power management board was causing the problem and is affected by recent recall.A philips field service engineer (fse) was dispatched to the customer site to provide additional assistance.

Manufacturer Narrative

G4: 13oct2020.B4: 20oct2020.The fse replaced the power management board to resolve the reported issue and the device returned to full functionality.Multiple good faith efforts were made to obtain patient's information with no response from the reporter.If additional information is later obtained, a supplemental report will be submitted.1.Thursday, september 24, 2020.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 power management board assembly (assy,pcb,pwr mgmt,v8000) was received for evaluation.Visual inspection revealed no anomalies.A failure investigation (fi) technician installed returned power management board into a fi ventilator to duplicate the reported issue.During the unit testing the power management board installed in the fi test ventilator to check for alarms and errors.The returned power management board was tested and the fi technician was unable to replicate the reported failure.Cycle testing did not replicate reported failure, and there was no spontaneous on/off behavior noted.The customer complaint was not verified.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: 10644281
• MDR Text Key: 211473175
• Report Number: 2031642-2020-03611
• 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: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• 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: 12/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2010
• 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
• Treatment: UNKNOWN PATIENT CIRUIT, MASK, AND HUMIDIFIER