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

Model Number V60

Device Problem Failure to Charge (1085)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020, date of report: 15dec2020.

Event Description

It was reported to philips that the battery was not charging.The device was not in clinical use at the time of the event.There was no report of patient or user harm.The customer requested that a philips field service engineer (fse) be dispatched to the customer site.

Manufacturer Narrative

G4:17dec2020 b4:(b)(4)2020 the field service engineer (fse) was dispatched to the customer site to provide additional assistance.The fse found that the unit was not powering up.The fse replaced the battery and the power supply to resolve the issue for the customer.The device passed testing, fully met specifications and was returned to use.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

It is unknown if the issue occurred while in clinical use.No patient or user harm reported.Multiple good faith efforts were performed for obtain further details regarding the patient's context of use; however, no response was provided.The power supply was returned for failure investigation.The customer complaint verified.Root cause was failure of power supply component.

Manufacturer Narrative

The device was not being used for medical treatment; no further details were provided regarding the event.No patient or user harm was reported.

Manufacturer Narrative

The battery was then returned to failure investigations, and it was reported that while testing the battery, the unit would not power on when the battery was the only power source.In addition, it was noted that an error was generated while cycling the power on and off (check vent battery failed alarm).

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11016751
• MDR Text Key: 222652795
• Report Number: 2031642-2020-04564
• 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,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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: 02/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2011
• 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