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

Model Number V60

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Read Input Signal (1581)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020.Date of report: 31jul2020.

Event Description

User interface (ui) assembly was returned for analysis.During testing of the ui it was found that the touchscreen response was erratic and had intermittent sensitivity to touch when any soft button was pressed.The unit was failing operational test and could not calibrate.There was no patient involvement.The product analysis technician inspected the ui assembly.The product analysis technician reported that the root cause of the reported issue was due to supplier workmanship issues.

Manufacturer Narrative

G4: 04aug2020 b4: (b)(6) 2020 information was received that the ui (user interface) assembly was retested to try to duplicate the touchscreen issue of intermittent sensitivity to touch and failing of operational and calibration test.The reported issue could not be replicated and no fault was found on the returned ui 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
• 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: 10353371
• MDR Text Key: 202537728
• Report Number: 2031642-2020-02590
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1