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

Model Number V60

Device Problems Component Missing (2306); Device Displays Incorrect Message (2591); Operating System Becomes Nonfunctional (2996)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The initial complaint was filed under the mfr report#: 2031642-2020-01993.Because of philips system issue.We are sending the following information: follow up#1: 23nov2020.Date of report: 17mar2021 the service technician replaced the power management printed circuit board assembly (pcba), liquid crystal display (lcd) assembly, pcba user interface, lcd tray, lcd cable, rp-screw.The cover top, rear gray, label option avaps (average volume assured pressure support), label c-flex, label battery, label positive pressure ventilation (ppv) and power cord retainer were replaced.Preventive maintenance (pm) kit, shipping box, pcba to lcd.The device passed all preventive action tests.Based on information provided and/or service performed it has been confirmed unit did not meet product specifications.Follow up#3: 011feb2021.Date of report: 17mar2021.The liquid crystal display (lcd), and user interface (ui) pcb were returned for analysis.The returned lcd and ui pcba was installed in the fi test ventilator in an attempt to duplicate the reported problem.An investigation was performed and the customer complaint was verified.Failure (burn out) of ccfl resulted in dim screen/unresponsive brightness control.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.

Event Description

The customer reported high priority alarms when powering on the unit.Th e customer found error codes in the significant even logs.The customer also indicated the unit's touchscreen froze.The service technician confirmed the reported complaint.The unit showed a 35 volt failure error, so the power management printed circuit board assembly needed to be replaced.The liquid crystal display was very dark and needed replacement.The top cover was also broken and needed replacement, along with the rear bezel.The rear bezel, avaps (average volume assured pressure support) label, c-flex label, battery label, and positive pressure ventilation label will need replacement.The power cord retainer was missing and needs replacement.There was no patient involvement and the unit was not in use at the time of the reported problem.

• 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: 11510163
• MDR Text Key: 246464976
• Report Number: 2031642-2021-00977
• 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
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• 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: 01/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2010
• 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