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

Model Number V60

Device Problems Crack (1135); Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 28jan2020.

Event Description

It was reported that the unit had a break on the external portion of the left touch panel.It was also reported that the "alarm mute" and "alarm reset" buttons on the touchscreen are unresponsive.It was also reported that the top cover had a crack.There was no patient involvement.The manufacturer's international service technician performed troubleshooting and confirmed the reported issue.The manufacturer's international service technician replaced the user interface assembly to address the touch failure and replaced the top cover to address the crack.

Manufacturer Narrative

G4: 23jun2020 b4: (b)(6)2020.User interface (ui) assembly was returned to failure investigation for analysis.Visual inspection of the user interface (ui) revealed no evidence of damage or contamination.A failure investigation (fi) technician verified the assembly was within specifications, the fi technician installed the ui into a fi ventilator and tested the device.They were not able to duplicate the reported failure of touchscreen unresponsive.The determination not could be made that the device failed to meet specifications, the user interface functioned as it should.No fault found with this assembly.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: 9640068
• MDR Text Key: 184199248
• Report Number: 2031642-2020-00332
• 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: 01/13/2020

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: Other
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 07/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1