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: 14dec2020.

Event Description

It was reported to philips that the battery is not charging; noted issue due to the battery charging indicator not illuminating.The device was not in clinical use at the time of the event.There was no report of patient or user harm.The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The customer reports that the 24 volts is missing.The rse advised the customer to measure the voltage with a dc volt meter coming off of the power supply and found that the 24 volts was missing.The rse advised the customer to replace the power supply.

Manufacturer Narrative

G4:21dec2020.B4:22dec2020.The customer stated that were no fault codes displayed on the device and the battery of the device was replaced in june 2020.The unit¿s power supply was replaced and corrected the issue.All the required performance verification and test procedures in the service manual were performed and the device passed and was placed back into 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.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11009144
• MDR Text Key: 222040260
• Report Number: 2031642-2020-04540
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2013
• 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