MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number V200

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: (b)(6) 2018.Date of report: 31dec2018.The philips service engineer (se) inspected the device.The se verified the reported issue.The se removed the power to the blower motor controller (bmc) and the unit turned on.The se replaced the power supply and found smoke coming from the bmc.The se will replace the bmc.

Event Description

It was reported that the ventilator generated a 24 volts failed error code.There was no patient involvement.The event date was not specified; estimate used.

Manufacturer Narrative

Date of report: 16 jan 2019.Date rec¿d by mfr: 08 jan 2019.The philips service engineer replaced the power supply and blower motor control to address the issue and the ventilator passed all testing.

Manufacturer Narrative

Date rec¿d by mfr : 03mar2019.A power supply assembly was returned to philips for analysis.A visual inspection of the returned component was performed, no notable conditions were found.The returned component was installed into a test ventilator for analysis.An investigation was performed and the product analysis technician reported that the root cause was isolated to a component (c56) in the power supply.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: V200 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, INC; 2271 cosmos court; carlsbad CA 92011
• MDR Report Key: 8206468
• MDR Text Key: 131773834
• Report Number: 2031642-2018-03098
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K102054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1