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: 02nov2020.

Event Description

Battery not charging.Yellow battery light is still flashing yellow even though it was left to charge over night.There was no patient involvement.

Manufacturer Narrative

G4:08apr2021.B4:13apr2021.The device was evaluated and confirmed remotely by a philips remote service engineer (rse).Rse advised the caller that the battery or pm pcb may be faulty.The rse did discover the battery is from 2019.The rse advised the caller to leave the unit plugged in over the weekend to see if the led would continue to flash.The caller was asked to call back if any further assistance is needed on this matter.Multiple attempts to retrieve device repair or diagnostic information have yielded no response from the customer.It is unknown if any parts or repair has been conducted.The alleged device malfunction could not be confirmed.If new information is received, a supplemental report will be submitted.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 device was evaluated and confirmed remotely by a philips remote service engineer (rse).Rse advised the caller that battery may be faulty or pm pcb may be faulty.The rse did discover the battery is from 2019 and advised the caller to leave unit plugged in over the weekend to see if the led would continue to flash on monday.Caller was ask to call back if any further assistance is needed on this matter.Multiple attempts to retrieve device repair or diagnostic information has yielded no response from the customer.It is unknown if any parts or repair has been conducted.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 10774654
• MDR Text Key: 215966915
• Report Number: 2031642-2020-04024
• 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,Followup
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 10/16/2020; 10/16/2020
• Supplement Dates FDA Received: 04/13/2021; 08/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2019
• 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