MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC. V60 VENTILATOR; VENTILATOR, CONTINUOUS

Model Number V60

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reported that the ventilator was alarming due to a blower temperature high occurrence.The customer reported the unit was in use on a patient and there was no patient harm.A prolonged blower temperature high occurrence may result in a vent inop during normal ventilation operation.Vent inop is a high priority condition that precludes safe operation of the ventilator.A vent inop alarm displays on the screen, turns on remote alarm interfaces, and disables oxygen flow and blower operation.The patient must be placed on another means of ventilatory support.The manufacturers field service engineer (fse) was unable to duplicate the reported problem.Review of the device diagnostic history noted the occurrence as reported.The fse replaced the blower and motor controller pcb board to address the findings and reported problem.Performance verification testing was completed per operating specifications and passed.

Manufacturer Narrative

Conclusion / root cause: the motor controller (mc) printed circuit board assembly (pcba) and blower assembly was tested and no failures were identified.The reported error code could not be duplicated.This report is being submitted as part of the remediation for capa (b)(4).

• Brand Name: V60 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC.; 2271 cosmos ct.; carlsbad CA 92011
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: nancy ataide ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 3965352
• MDR Text Key: 4557967
• Report Number: 2031642-2014-00760
• 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,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2014
• 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
• Date Manufacturer Received: 07/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2011
• 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