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

Model Number V60

Device Problem Gas/Air Leak (2946)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 21sep2020.

Event Description

The customer reported a ventilator with a low tidal volume alarm and a low leak-co2-rebreathing risk alarm.This event was reported as having occurred during clinical use - there was no allegation of harm associated with this event.

Manufacturer Narrative

G4: 29dec2020 b4: (b)(6) 2021.The device was in testing while being set-up for use.The customer had a standby ventilator which was immediately connected to patient and there was no delay in therapy.The customer requested that a philips field service engineer (fse) be dispatched to the customer site.The fse confirmed that the device was alarming low leak ¿ co2 rebreathing risk.The fse replaced the gas delivery system (gds) to resolve the issue and bring the device back to functionality.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: 10564498
• MDR Text Key: 208514785
• Report Number: 2031642-2020-03399
• 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: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• 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
• Date Manufacturer Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2014
• 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