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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 Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 10/04/2019.
 
Event Description
The customer reported a distorted display in the reading blocks.There was no patient or user harm reported.
 
Manufacturer Narrative
Date rec¿d by mfr: 30oct2019.Date of report: 31oct2019.The customer troubleshot with tech support over the phone.The customer replaced the main central processing unit (cpu) to address the issue.The issue was resolved, the device has been tested, and the device now functions as intended.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 Key9157190
MDR Text Key187611009
Report Number2031642-2019-09975
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 09/26/2019
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 No Information
Device Model NumberV200
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/26/2019
Initial Date FDA Received10/04/2019
Supplement Dates Manufacturer Received09/26/2019
Supplement Dates FDA Received10/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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