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

Model Number V60

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 24nov2020.

Event Description

It was reported to philips that the device had a serial peripheral interface bus(spi bus) issue.The device was not being used on a patient at the time of the event.There was no patient or user harm reported.

Manufacturer Narrative

G4:10feb2021; b4:19feb2021; h11:g5:k102985.H11: b5: the customer replaced the central processing unit (cpu) to resolve previous issues and needs software options reinstalled and also had errors in the significant event logs.H10: three good faith efforts were made to obtain information regarding the contextual use and with no response from the reporter and therefore cannot be determined.The customer evaluated the device with assistance from a philips remote service engineer (rse).The rse recommended that the customer check the connection between the data acquisition printed circuit board assembly (da pcba) and the motor control cable.The customer stated that the connection was easily disconnected.Once the locks were engaged, the issue was resolved.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: 10901305
• MDR Text Key: 218927010
• Report Number: 2031642-2020-04247
• 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: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2013
• 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