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

Model Number V200

Device Problem Occlusion Within Device (1423)

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

The customer reported the ventilator alarmed due to an occlusion-svo.No patient involvement reported.

Manufacturer Narrative

The field service engineer (fse) confirmed the reported problem.The fse opened the machine, cleaned the patient circuit and the issue resolved.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 not a relationship of the device to the reported problem.Due to no part returning for failure investigation the root cause of the reported issue could not be determined.

• 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: robert corning ; 2271 cosmos court; carlsbad, CA 92011 ; 9093746996
• MDR Report Key: 7234120
• MDR Text Key: 98869763
• Report Number: 2031642-2018-00200
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00884838010970
• UDI-Public: (01)00884838010970
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2018
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2015
• 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