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

Model Number V60

Device Problem Material Discolored (1170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2020, date of report: 30nov2020.

Event Description

The customer reported the numbers jump around when trying to set unit and background is pink.There was no patient involvement.

Manufacturer Narrative

The field service engineer (fse) evaluated the incident and confirmed that the device was not functioning properly and confirmed the reported problem.The front bezel was replaced, and this resolved the nav-ring issue for the customer.It was also confirmed that the lcd needed to be replaced and there was loose hardware that needed to be replaced.The lcd assembly was replaced to address the pink background.The front bezel assembly was returned for failure investigation.Visual inspection of the ui front bezel assembly (check mark) revealed no evidence of damage or contamination as received.The nav-ring potentiometer pre-load test failed.Contamination buildups were found on the rotary adjustment assembly (nav-ring) matrix that causes the nav-ring not functioning.The lcd, user interface assembly was returned for failure investigation, and it passed all testing.A pink screen display failure could not be duplicated.There were no faults found on this returned lcd user interface assembly.

• 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; carlsbad CA
• Manufacturer Contact: bill cole ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 10925392
• MDR Text Key: 219339859
• Report Number: 2031642-2020-04338
• 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: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: V60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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