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

Model Number V60

Device Problem Intermittent Continuity (1121)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2019.Date of report: 23dec2019.

Event Description

The customer reported during pm (preventive maintenance) service they found the touchscreen with intermittent operation.The field service engineer (fse) confirmed intermittent touchscreen operation and found the unit has intermittent touchscreen operation during parameter changes.The fse performed touchscreen calibration, but the issue was not resolved.The device was not in clinical use at the time the issue was discovered, therefore, there was no patient or user harm reported.The fse replaced the touchscreen to resolve the issue.The fse powered on the unit and the touchscreen was operational.

Manufacturer Narrative

G4: 24mar2020 b4: (b)(6)2020.Touchscreen assembly was received for evaluation.There were no signs of damage or contamination during visual inspection.After testing, it was determined that the ul_lr and ur_ll resistance and resistance ratio were out of specification, which caused the failure.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: 9511788
• MDR Text Key: 182143411
• Report Number: 2031642-2019-10938
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00884838020054
• UDI-Public: (01)00884838020054
• Combination Product (y/n): N
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

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
• Device Operator: No Information
• Device Model Number: V60
• Device Catalogue Number: 1053617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1