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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 Problems Mechanical Problem (1384); Device Emits Odor (1425)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 04/24/2019.The service engineer (se) inspected the device.The se replaced the blower assembly and the blower motor controller to address the issue and the ventilator passed all testing.
 
Event Description
It was reported that the ventilator had a burning smell when powered on.The service engineer (se) inspected the device and found an air valve liftoff failure error code in the ventilator diagnostic logs.No patient involvement.Event date not specified, estimate used.
 
Manufacturer Narrative
Date rec¿d by mfr : 06aug19.Failure analysis on the returned blower assembly and blower motor controller board (bmc) shows that during visual inspection of the blower motor controller pcba revealed evident of burnt damaged j3 connector.The damaged j3 connector created the 1012 error code.The blower wire installed incorrect created the damaged on the j3 connector.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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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 Key8547111
MDR Text Key143056084
Report Number2031642-2019-02424
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 company representative,foreig
Type of Report Initial,Followup
Report Date 03/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2019
Was the Report Sent to FDA? No
Date Manufacturer Received03/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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