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

Model Number V60

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 20oct2020.

Event Description

It was reported to philips a lag in reaction of touchscreen and illumination failure in power light emitting diode (led).The reported issues were observed during periodic maintenance.The touchscreen and power switch overlay were determined to be faulty and need to be replaced.Waiting for an order from the customer, the repair completion date has not been fixed.The device did not have patient involvement at the time the issue was discovered, therefore, there was no patient or user harm reported.

Manufacturer Narrative

G4: 26oct2020; b4: 27oct2020.The service technician confirmed a lag in the reaction from the touchscreen was confirmed.Therefore, the touchscreen was replaced and the phenomenon was resolved.It was observed that the power on/off light emitting diode (led) was unable to illuminate.Therefore, the power switch overlay was replaced and the illumination failure in power led was resolved.Periodic maintenance 1 was performed.The following parts were replaced to prevent failure in accordance with the maintenance procedure: oxygen inlet filter, inlet air filter, cooling fan filter overall checking, cleaning, run testing, and a function test were performed.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

G4:26jan2021.B4:28jan2021.D4: udi#: (b)(4).A touchscreen assembly was returned for analysis.Visual inspection of the returned touchscreen assembly revealed no evidence of damage or contamination.An investigation was performed, and the reported complaint touchscreen failed is not duplicated.There is no fault found on this returned touchscreen assembly.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: 10708698
• MDR Text Key: 213697616
• Report Number: 2031642-2020-03789
• 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
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2017
• 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