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

Model Number V60

Device Problem Computer Operating System Problem (2898)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 05nov2020.

Event Description

It was reported the system will not boot up.The unit was in clinical use and there was no patient or user harm reported.

Manufacturer Narrative

G4:18feb2021 b4:19feb2021.H11: g5:k102985.H10: philips has not been authorized to repair the unit, the customer has not authorized repair for this device at this time, the quote was not accepted by the customer.Based on information provided and/or service performed, the customers alleged malfunction was not confirmed.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

G4:02apr2021 b4:(b)(6)2021 the device was in testing when the issue was discovered.There was no patient involvement.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: 10796722
• MDR Text Key: 217365828
• Report Number: 2031642-2020-04089
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2020

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: No Information
• Device Model Number: V60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 10/20/2020; 10/20/2020
• Supplement Dates FDA Received: 02/19/2021; 04/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2013
• 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
• Treatment: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER