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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 Poor Quality Image (1408)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of this report: 08 jun 2020.
 
Event Description
It was reported that the unit had a white display.There was no patient involvement.The manufacturer's remote service technician performed troubleshooting with the customer.The technician recommended that the customer replace the video graphics array (vga) card.The customer reported that the vga card was replaced and the issue was resolved.The unit was returned to service.
 
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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 Key10131240
MDR Text Key194776877
Report Number2031642-2020-02006
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K981072
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 05/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2020
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/21/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2008
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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