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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 Poor Quality Image (1408); Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 03jul2019.A follow up report will be submitted once the evaluation is complete.
 
Event Description
The customer reported black lines running through half of the display, the other half is missing.There was no patient involvement.
 
Manufacturer Narrative
Date rec'd by mfr: 05aug2019.Date of report: 12aug2019.The customer's biomed confirmed the display failure.The customer's biomed stated that no parts were replaced as the issue was due to a loose connection.The device is back in service.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 Key8760793
MDR Text Key150159045
Report Number2031642-2019-04228
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 06/19/2019
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 NumberV200
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/19/2019
Initial Date FDA Received07/03/2019
Supplement Dates Manufacturer Received06/19/2019
Supplement Dates FDA Received08/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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