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

Model Number V60

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 62021.Date of report: 02mar2021.

Event Description

The customer called into technical support (ts) reporting that the device is displaying a 35 volt diagnostic code.The customer reported there was no patient involvement at the time the issue was discovered.

Manufacturer Narrative

The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed reported problem.Customer has advised the v60 is affected by power management board fco # (b)(4).Quote was provided for service.Multiple good faith efforts were made to obtain information regarding device evaluation, repair, and operational status with no response from the reporter and therefore cannot be determined.A review of servicemax found no parts were ordered or service requested and the case was closed.If the decision is made to have the device evaluated and repaired by philips a new service order will be opened and will be captured through philip's normal complaint procedure.

Manufacturer Narrative

The service engineer implemented the field change order replacement of the new pm pcba to resolve reported problem.After installation of the new pm pcba.The unit successfully passed testing.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11400642
• MDR Text Key: 242579105
• Report Number: 2031642-2021-00791
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2021

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
• 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; 07/24/2021
• Supplement Dates FDA Received: 07/19/2021; 08/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1622-2020
• Patient Sequence Number: 1