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

Model Number	V60
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 03june2019.A follow-up report will be submitted once the evaluation is complete.
Event or Problem Description
The customer reported that the v60 unit had a defective touch screen.The device was in clinical use at the time of the malfunction, but there was no patient or user harm.
Additional Manufacturer Narrative
Date rec¿d by mfr : 28jun2019, date of report : 25jul2019.The philips field service engineer (fse) confirmed the touchscreen failure.The fse replaced the touchscreen to resolve the issue.No parts have been returned, therefore the root cause cannot be determined.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.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.
Additional Manufacturer Narrative
G4: 30aug2019; b4: 03sep2019.Failure analysis on the returned touch screen shows that the ul_lr and ur_ll resistance were out of spec.Fault was found on this returned touchscreen.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
• Common Device Name: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 8663976
• Report Number: 2031642-2019-03416
• Device Sequence Number: 2268884
• Product Code: MNT
• UDI-Device Identifier: 00884838025738
• UDI-Public: (01)00884838025738
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2019

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
• Operator of Device: Health Professional
• Device Model Number: V60
• Device Catalogue Number: U1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 05/16/2019; 05/16/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 07/25/2019; 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER.