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

Model Number V60

Device Problem Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 31aug2020.

Event Description

The customer reported a misalignment in the touchscreen.The service technician confirmed the touched position was misaligned in the touch screen, so the touchscreen was calibrated but the phenomenon did not improve.The device did not have patient involvement at the time the issue was discovered, therefore, there was no patient or user harm reported.The service technician replaced the touchscreen then confirmed the phenomenon was improved.No other abnormality was confirmed but the following parts were replaced as regulated by periodic maintenance procedure to prevent failure: oxygen inlet filter, air inlet filter and cooling fan filter.The unit was checked overall, cleaned, run in tested and functionally tested.

Manufacturer Narrative

G4: 13oct2020 b4: (b)(6) 2020 d4: udi:# (b)(4) a touchscreen assembly was returned for analysis.Visual inspection of the touchscreen assembly revealed no scratching or other damage.An investigation was performed and the customer complaint verified.Resistance measurement fail.After calibration, some buttons do not respond correctly.Root cause is failure of touchscreen 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: 10474477
• MDR Text Key: 206140840
• Report Number: 2031642-2020-03050
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1