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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number V200
Device Problem Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2021
Event Type  malfunction  
Event Description
The customer called technical support (ts), reporting that the device has a loud noise.
 
Manufacturer Narrative
Upon further investigation, this case has been downgraded as noise does not affect the unit¿s performance or function and therefore, the event presents no risk of patient harm or injury.Therefore, this complaint no longer meets reportability requirements.
 
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Brand Name
RESPIRONICS
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, LLC
2271 cosmos court
carlsbad CA 92011
Manufacturer (Section G)
RESPIRONICS CALIFORNIA, LLC
2271 cosmos court
carlsbad CA 92011
Manufacturer Contact
melissa abbott
2271 cosmos court
carlsbad, CA 92011
7609187300
MDR Report Key11682678
MDR Text Key246218098
Report Number2031642-2021-03409
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberV200
Device Catalogue Number1060264
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Distributor Facility Aware Date03/17/2021
Date Manufacturer Received11/04/2021
Date Device Manufactured11/14/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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