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

Model Number V60

Device Problems Device Alarm System (1012); Failure to Zero (1683)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2018.Date of report: 08aug2019.The manufacturer¿s international service technician confirmed the reported issue.The manufacturer¿s international service technician replaced solenoid 3 and the data acquisition pcba to resolve the reported issue.Root cause: the data acquisition pcba was returned for failure investigation (fi) and the reported issue was duplicated.The root cause was traced back to a defective u6.This mdr has been reassessed as reportable after a request from the fda on march 1, 2019 to review complaints from 29 nov 2017 to 29 nov 2018.As this has been reassessed, it will appear to be a late mdr.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.

Event Description

During preventative maintenance, it was found that the unit had an error code message of proximal pressure sensor auto zero failed.There was no patient involvement.

• 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: melissa abbott ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 8873854
• MDR Text Key: 153727585
• Report Number: 2031642-2019-05615
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K082660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• 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: 03/26/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2017
• 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