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

Model Number V60

Device Problem Self-Activation or Keying (1557)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2021.Date of report: 04mar2021.

Event Description

It was reported to philips that the device was turning itself on over the weekend.The device was not in clinical use at the time of the event.There was no report of patient or user harm.The customer stated that when the device was tested at the workshop during the day just on battery no fault was replicated, but when the customer returned the next morning he noticed the device was on, and power restored event was logged in event log.The customer was sure he didn't leave the device in stand by mode and had it shut down before leaving work.The rse advised the customer to send the drpt report, but he doesn't have teraterm to extract the report, but stated no critical error was seen in the event log.The customer mentioned the device was purchased in 2012 and the battery hasn't been replaced since then.The re advised the customer the battery has to be replaced every 5 years and advised to check the year of manufacture on the battery.The rse advised to send to healthcare repair facility (hrf) for further assessment.

Manufacturer Narrative

G4:(b)(6)2021.B4:(b)(6)2021.The device was evaluated at the healthcare repair facility (hrf) and the technician replaced the battery due to intermittent disconnection to ventilator and greater than 5 years old.Full performance verification testing completed after the repair and the device was returned to the customer.The defective battery was reported to be over 5 years old and past its recommended replacement interval per the v60 service and user manual.Based on this information, it was can be concluded that the device functioned as designed and the reported failure occurred due to maintenance issue.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: 11418818
• MDR Text Key: 240607871
• Report Number: 2031642-2021-00842
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

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: 02/04/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2012
• 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