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

Model Number V60

Device Problems Poor Quality Image (1408); Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 23apr2020.

Event Description

The customer reported a dim display.There was no patient involvement.The manufacturer's technical services (ts) confirmed the reported issue.The customer was provided with the part number for the (user interface) ui assembly and advised customer to upgrade software to 2.1 or higher.The customer replaced the defective user interface and upgraded software to 2.30 to address the reported problem.The unit successfully passed the required performance verification test.

Manufacturer Narrative

G4: 08jul2020 b4: (b)(6) 2020 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.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: 9992809
• MDR Text Key: 189001903
• Report Number: 2031642-2020-01514
• 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: 04/06/2020

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: Health Professional
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 04/06/2020
• Supplement Dates FDA Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1