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

Model Number V60

Device Problem Failure to Read Input Signal (1581)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Event date: (b)(6) 2018.Date of report: 16oct2018.International udi: (b)(4).Philip's international service technician confirmed the reported issue.Philip's international service technician performed calibration on the device to address the reported problem.The unit successfully passed the required performance verification test.

Event Description

The customer reported a touch screen failure.The device was not in use at the time of the reported event; therefore, there was no patient involvement.The event date was not specified; estimate used.

Manufacturer Narrative

Date of event: (b)(6) 2018.Date of report: (b)(6) 2018.Correction: philip's international service technician replaced the defective touch screen to address the reported problem.The unit successfully passed the required performance verification test.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: 7972179
• MDR Text Key: 124114981
• Report Number: 2031642-2018-02216
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: 00884838020054
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2018
• 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
• Date Manufacturer Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1