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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR
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RESPIRONICS CALIFORNIA, INC ESPRIT VENTILATOR Back to Search Results
Model Number V1000
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2021.Date of report: 18feb2021.
 
Event Description
It was reported that the ventilator had an error code indicating inhalation autozero test failure.There was no patient involvement.The service engineer (se) inspected the device.The se confirmed the reported issue.The se replaced the air/exhalation flow sensor to address the reported issue.The unit was checked overall, run in tested, cleaned, functionally tested and no abnormality was confirmed.
 
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Brand Name
ESPRIT VENTILATOR
Type of Device
VENTILATOR
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
Manufacturer (Section G)
RICA
2271 cosmos court
carlsbad CA 92011
Manufacturer Contact
yobana sanchez
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key11345739
MDR Text Key240463501
Report Number2031642-2021-00652
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K981072
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberV1000
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/24/2010
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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