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; report date: (b)(6) 2020.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

It was reported to philips that they had 2 batteries in this device, and it would not charge either one of them.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 stated that they had 2 batteries in this unit it would not charge either one of them.Verified voltage was low and unit should have charged them.The rse provided the part information for a replacement power management pcba.A good faith effort was made to the customer to obtain additional information on evaluation and repair.

Manufacturer Narrative

Multiple good faith efforts were made to obtain information regarding context of use, predefined battery questions, device evaluation, repair, and operational status with no response from the reporter and therefore cannot be determined.If additional information is later obtained, the complaint will be reopened.1.(b)(6) 2020 10:26 am emailed.(b)(6).2.(b)(6) 2020 1:27 pm emailed.(b)(6).3.(b)(6) 2020 3:07 pm emailed (b)(6).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: 10856492
• MDR Text Key: 218574664
• Report Number: 2031642-2020-04182
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• 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: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2016
• 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