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

Model Number V200

Device Problems Device Emits Odor (1425); Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Patient information was requested and was not provided.

Event Description

The customer reported a burning smell coming from inside and the device would not power on.The customer reported there was patient involvement and no patient harm.

• Brand Name: V200 VENTILATOR
• Type of Device: VENTILATOR, CONTINUOUS, 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: wendy chadbourne ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 6124643
• MDR Text Key: 61020863
• Report Number: 2031642-2016-03218
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K102054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V200
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2010
• 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