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

Model Number V60

Device Problem Material Discolored (1170)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 10/30//2019.

Event Description

The customer reported the touchscreen is discolored and dark.There was no patient involvement.

Manufacturer Narrative

Date received by manufacturer: 18dec2019, date of report: 19dec2019.The manufacturer¿s international service technician confirmed the reported issue.The manufacturer¿s international service technician replaced the defective user interface to address the reported problem.The unit successfully passed the required performance verification test.The determination could not be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is a relationship of the device to the reported problem.Part was not returned to failure investigation (fi).The root cause cannot be determined until the device is returned and investigated.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.

Manufacturer Narrative

G4: 05feb2020.B4: 06feb2020.The user interface (ui) assembly was returned to failure investigation (fi) for evaluation.Visual inspection of the user interface assembly revealed no evidence of damage or contamination.The user interface assembly will be installed in the fi test ventilator in an attempt to duplicate the reported problem.During debugging, found cold cathode fluorescent lamp (ccfl) burn out.Due to the damage to the (ccfl) backlight no further testing required.The determination could be made that the device failed to meet specifications.The device was not being used for treatment when the reported event occurred, and there is a relationship of the device to the reported problem.The burn out cold cathode fluorescent lamp (ccfl) backlight causes the dim display.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: 9258165
• MDR Text Key: 177005553
• Report Number: 2031642-2019-10350
• 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: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1