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

Model Number V60

Device Problem Defective Alarm (1014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 05nov2020.

Event Description

The customer reported that their philips v60 ventilator experienced a primary alarm failure.The device was not in clinical use at the time the issue was discovered.There was no patient or user harm reported.

Manufacturer Narrative

G4:22feb2021.B4:23feb2021.H11:g5:k102985.H10: the device was evaluated by the customer and a philips remote service engineer (rse).The customer confirmed the reported issue via the event log.The rse advised the customer to ensure both primary speakers were connected and to ohm out the speakers looking for a value of 8 ohms.If a value other than 8 ohms is given then it was advised that the customer replace the speakers.If the issue continued than the customer was advise to replace the central processing unit (cpu).Furthermore, attempts were made to follow ups with the customer following the event, however, customer provided minimal to no information regarding the event.It was discovered that the initial reporter no longer works at the facility and information regarding the resolution could not be determined because the event was not documented in the system.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: 10795958
• MDR Text Key: 217146677
• Report Number: 2031642-2020-04081
• 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
• Report Date: 10/20/2020

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: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 02/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2016
• 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