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

Model Number V60

Device Problems Device Alarm System (1012); Computer Operating System Problem (2898)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 05jan2021.

Event Description

The customer called into technical support (ts) reporting that the devices alarm occurred and the unit rebooted by itself.The device was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or user.Neither patient therapy delay nor medical intervention was reported.The manufacturer's field service engineer (fse) evaluated the device with the assistance of the customer and confirmed the reported problem that the reported alarm was displayed and the alarm failed to be silenced.The unit was replaced with the same model.The reproducibility was checked in a hospital me's room but the applicable phenomenon had not recurred.The fse replaced the cpu(central processing unit) board to resolve the reported issue.The unit passed the required performance verification tests per philips standards.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11121837
• MDR Text Key: 226562191
• Report Number: 2031642-2021-00039
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838033832
• UDI-Public: (01)00884838033832
• 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
• Report Date: 07/15/2021

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: 1076709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 05/19/2021
• Supplement Dates FDA Received: 07/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2020
• 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 CIRCUIT, MASK, AND HUMIDIFIER