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.(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 the device came from another depot and that the battery is 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 device was evaluated by the customer with assistance from a philips remote service engineer (rse).The customer connected to ac and verified it was not charging.The customer stated the device would not power on at this point on ac or dc.The customer verified that the battery was from 2019.The battery charging voltage is.007 connected to ac battery.Once it was disconnected the unit was off.The rse advised the customer to verify the voltage coming from the power supply and found no voltage.The customer stated 110 vac at the power cord going into the unit.And did not have meter leads to verify 110 vac to the input of the power supply.The customer was going to verify if the power supply is getting the 110 vac input and call back.

Manufacturer Narrative

G4:08jan2021.B4:13jan2021.Multiple good faith efforts were made to obtain information regarding 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 and 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.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• MDR Report Key: 11022816
• MDR Text Key: 222317150
• Report Number: 2031642-2020-04595
• 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: 11/19/2020

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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2014
• 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