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

Model Number V60

Device Problem Calibration Error (1078)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reported that the touchscreen does not seem to stay calibrated.There was no patient involvement.

Manufacturer Narrative

During further investigation (fi) a visual inspection of the user interface assembly revealed that there were no signs of damage or contamination found on the exterior of this unit.The customer returned touchscreen will be installed into an fi test gui and the gui will be attached to an fi test ventilator.The ventilator was booted up into the diagnostic mode and a successful touchscreen calibration was performed.The fi test vent was booted up into normal ventilation mode and deliver breaths.The touchscreen was exercised by entering different menus and changing the settings and no errors were produced while making the setting changes.The customer returned touchscreen was allowed to run for approximately 120 hours and no errors were generated.The customer returned gui was disassembled and a visual inspection of the interior was performed.No sign of damage or contamination was found and all wiring and connectors were routed correctly and secure.The gui was reassembled and reattached to the fi test ventilator.The ventilator was booted up into normal ventilation mode and deliver breaths.The touchscreen was exercised by entering different menus and changing various settings with no errors produced while making the setting changes.The ventilator was booted up into diagnostic mode and a successful touchscreen calibration was performed.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 no relationship of the device to the reported problem.The customer returned gui was tested and no failures were identified.

• 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
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 7023431
• MDR Text Key: 91906714
• Report Number: 2031642-2017-03511
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2017
• 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: 11/13/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1