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

Model Number V60

Device Problem Device Sensing Problem (2917)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 06oct2020.

Event Description

It was reported to philips that the device had a pressure sensor auto failure.The device was reported as being in use at the time of the event on a patient.The initial reporter confirmed that there was no adverse patient impact.

Manufacturer Narrative

G4:16dec2020.B4:17dec2020.The device was not being used on a patient at the time of the event.There was no patient or user harm reported.The device was received by philips bench repair.The bench found several machine pressure sensor auto zero failed error codes in the log.The errors were unable to reproduce during testing.The device was restarted multiple times and was working without any issues.The bench determined the problem may be intermittent and replaced the data acquisition printed circuit board assembly (da pcba) and solenoid valves.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

G4:10mar2021.B4:13mar2021.The returned data acquisition system was installed into the failure investigation (fi) test ventilator.The customer complaint was confirmed.The root cause was the failure of the machine pressure sensor, which was caused by u7 drifting out of calibration.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: 10636752
• MDR Text Key: 212483880
• Report Number: 2031642-2020-03590
• 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,Followup
• Report Date: 09/15/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 09/15/2020; 09/15/2020
• Supplement Dates FDA Received: 12/17/2020; 03/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2011
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK AND HUMIDIFIER