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

Model Number V60

Device Problems Nonstandard Device (1420); Failure to Zero (1683); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

Customer reported that the unit has an error code messages of air flow sensor calibration data error and proximal pressure sensor autozero failed.The customer reported there was no patient involvement.

Manufacturer Narrative

The field service engineer performed preventative maintenance and replaced the data acquisition (da) pcba to motor controller (mc) pcba cable.Unit passed required performance verification tests per philips standards.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.No parts returned to failure investigation; therefore, the root cause of the reported issue could not be determined.If parts are returned, the complaint will be reopened.

• 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: robert corning ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 7006230
• MDR Text Key: 91789329
• Report Number: 2031642-2017-03484
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-2061-2017
• Patient Sequence Number: 1