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

Model Number V60

Device Problems Failure to Charge (1085); Battery Problem (2885)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 03feb2021.

Event Description

The customer reported the battery was not charged, even a power cord was plugged.Not in use, no patient or user harm reported.

Manufacturer Narrative

G4:10feb2021.B4:04mar2021.H11:g5:k102985.H10: the field service engineer (fse) confirmed the reported failure of "battery failed." the failed error was displayed on the screen and the diagnostic error report.A quote was sent to the customer.Philips has not been authorized to evaluate the device at this time, as further servicing is pending customer reply.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

The field service engineer (fse) confirmed the reported failure.During servicing, the fse also observed that the power on/off light-emitting diode (led) was unable to illuminate, and the value was set to 100 % on an oxygen-concentration test, the accepted range was from 95 to 105 % inclusive, but a measured value was 94.1 %.The (fse) replaced the lithium-ion battery to resolve the issue.The unit was tested, and it was returned to service.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11274348
• MDR Text Key: 240332510
• Report Number: 2031642-2021-00418
• 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: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• 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
• Date Manufacturer Received: 07/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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