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

Model Number V200

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported that the backup battery is depleted.The customer reported there was no patient involvement.

Manufacturer Narrative

Device evaluation summary: the fse evaluated the device while onsite.Resolution and disposition: the fse replaced the backup battery to address the reported problem.Conclusion: 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.Root cause: n/a.

• 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: 6041371
• MDR Text Key: 57872427
• Report Number: 2031642-2016-02808
• 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,Followup
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2009
• 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