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

Model Number V60

Device Problems Failure to Read Input Signal (1581); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.(b)(6) 2021.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.

Event Description

The customer called into technical support (ts) reporting that the device keeps locking up and the touchscreen becomes unresponsive.The device was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or user.

Manufacturer Narrative

G4:22feb2021.B4:06mar2021.H11:g5:k102985.H10: the device was in clinical use at the time the reported issue was discovered; however, there was no harm to the patient or user.The device was swapped to another device.The initial reporter confirmed that there was no adverse patient impact.The manufacturer's field service engineer (fse) was dispatched to the site and confirmed the reported problem.The fse replaced the graphic user assembly (gui) to resolve the reported issue.Unit passed required performance verification tests was returned to service.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: 30apr2021.B4: 30apr2021.It was confirmed that it was observed prior to the device being used on a patient.There was no harm to the patient or user.The initial reporter confirmed that there was no adverse patient impact.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

G4:22apr2021.B4:26apr2021.It was reported that the device was in clinical use at the time the issue was discovered; however, it was confirmed that it was observed prior to the device being used on a patient.There was no harm to the patient or user.The initial reporter confirmed that there was no adverse patient impact.The customer evaluated the device with the assistance of the remote service engineer (rse) and confirmed reported problem.The customer replaced the gui assembly to resolve the reported issue.Unit passed required performance verification tests per philips standards.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: 11210956
• MDR Text Key: 229107845
• Report Number: 2031642-2021-00267
• 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,Followup
• Report Date: 12/28/2020

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: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 12/28/2020; 12/28/2020; 12/28/2020
• Supplement Dates FDA Received: 03/07/2021; 04/26/2021; 04/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2010
• 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 CIRCUIT, MASK, AND HUMIDIFIER