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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 Computer Operating System Problem (2898)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 26oct2020.
 
Event Description
It was reported to philips ventilator is not booting up.The service technician confirmed the reported issue and indicated the issue occurred during routine testing.The device did not have patient involvement at the time the issue was discovered, therefore, there was no patient or user harm reported.The power supply was replaced to resolve the reported issue and unit successfully pass performance specification testing after the repair was completed.
 
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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)
PHILIPS MEDICAL SYSTEMS
carlsbad CA
Manufacturer Contact
bill cole
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key10738078
MDR Text Key214800250
Report Number2031642-2020-03856
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 10/05/2020
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 NumberV1000
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/05/2020
Initial Date FDA Received10/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2010
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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