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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 Fluid/Blood Leak (1250); Failure of Device to Self-Test (2937)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2018.Date of report: 31dec2018.A follow-up report will be submitted once the investigation has been completed.
 
Event Description
It was reported that the ventilator was failing extended self test (est) with an error code "check valve 3 (cv3) leak".The customer found the cv3 laying in the gas outlet port.No patient involvement.The event date was not specified; estimate used.
 
Manufacturer Narrative
Date of report : 13feb2019 , date rec¿d by mfr : 12feb2019.The customer was provided with part number and price for the cv3.The customer stated to be short staffed and not able to get to the repair/service of the device.No other information was provided.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 Key8206979
MDR Text Key131766037
Report Number2031642-2018-03110
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 user facility
Type of Report Initial,Followup
Report Date 12/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2018
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
Date Manufacturer Received12/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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