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

Model Number V60

Device Problem Poor Quality Image (1408)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 06aug2020.

Event Description

The customer reported a ventilator with a dim display.There was no patient involvement / harm reported.This issue was addressed in-house by the customer - there was no on-site evaluation by the manufacturer.The customer reported that the replacement of the user interface assembly resolved this reported event.

Manufacturer Narrative

G4:23nov2020.B4:25nov2020.The user interface (ui) assembly was returned for evaluation.Visual inspection of the user interface assembly was received with damage to the touchscreen.A failure investigation (fi) technician installed the user interface (ui) assembly into a fi ventilator to duplicate the reported issue.During the unit testing the user interface (ui) assembly was installed in the fi test ventilator and it was found that a burnt out cold cathode fluorescent lamp (ccfl) backlight causes the dim display.Fault was found on this returned user interface (ui) assembly and the customer complaint was 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.

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 10376383
• MDR Text Key: 202880208
• Report Number: 2031642-2020-02676
• 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: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1