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

Model Number V60

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 11sep2020.

Event Description

It was reported to philips that the device had a central processing unit test failure.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: 30oct2020 b4: (b)(6) 2020 philips field service engineer (fse) was dispatched to the customer site.The reported issue was confirmed and traced to a faulty central processing unit printed circuit board assembly (cpu pcba).The fse replaced the cpu pcba to resolve the reported issue.The device passed performance verification testing and was placed back into service.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: 29oct2021.B4: 31mar2021.The central processing unit was returned for investigation.Testing installed the returned cpu assembly into a known good test ventilator unit.Boot unit in normal operation mode and check for alarms and errors.After testing, the customer complaint was verified.The root cause were defective solder joints in the bga u3.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: 10522541
• MDR Text Key: 207716564
• Report Number: 2031642-2020-03226
• 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: 08/20/2020

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: 10/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/11/2020
• Supplement Dates Manufacturer Received: 08/20/2020; 08/20/2020
• Supplement Dates FDA Received: 11/01/2020; 04/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2010
• 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