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

Model Number V60

Device Problems Intermittent Continuity (1121); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 02march2020.

Event Description

The customer reported an intermittent diagnostic code consistent with primary alarm failure.The customer reported the problem is intermittent and has replaced the cpu (central processing unit) board within the last few months.After replacing the power management board the unit is displaying 5 volt power supply failure.It is unknown if the device did have patient involvement at the time the issue was discovered, however, there was no patient or user harm reported.

Manufacturer Narrative

G4: 22may2020.B4: 23may2020.The customer confirmed the device was not in clinical use at the time the issue was discovered.The service technician confirmed the unit showing primary alarm and 5 volt power supply failed alarms.The service technician replaced the power management board to resolve the reported 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
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 9777406
• MDR Text Key: 194120973
• Report Number: 2031642-2020-00692
• 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: 02/06/2020

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: 02/06/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 05/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1