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); Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the ventilator did not power on and had the smell of smoke.There was no patient involvement.

• 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: betty harris ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 8574245
• MDR Text Key: 143955565
• Report Number: 2031642-2019-02726
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2019
• 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: 04/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2005
• 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