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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS CALIFORNIA, INC V200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number V200
Device Problem Poor Quality Image (1408)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2018.Date of report: 05dec2018.No phone number provided.A follow-up report will be submitted once the investigation has been completed.
 
Event Description
It was reported that the ventilator screen failed, the screen was black.No patient involvement.The event date was not specified; estimate used.
 
Manufacturer Narrative
Date of report: 20dec2018.Date of manufacturer: 16dec2018.It was reported that the customer ordered a video graphic array (vga) controller printed circuit board assembly (pcba) to address the issue.No parts were received at philips for evaluation, therefore, a root cause could not be established.
 
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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 Key8136026
MDR Text Key129585064
Report Number2031642-2018-02689
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K102054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 11/19/2018
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 No Information
Device Model NumberV200
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/19/2018
Initial Date FDA Received12/05/2018
Supplement Dates Manufacturer Received11/19/2018
Supplement Dates FDA Received12/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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