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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE / INNER COOL ESPRIT VENTILATOR
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PHILIPS HEALTHCARE / INNER COOL ESPRIT VENTILATOR Back to Search Results
Model Number V1000
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2018.On (b)(6) 2018.Customer reports display to main printed circuit board cable has a broken connector.Philips technical support provided part number (part # 1016006).No parts were returned for failure investigation; therefore, the root cause at the component level could not be determined.
 
Event Description
Customer requests part number for the display cable for the mainboard.No patient/user harm reported.The event date was not specified; estimate used.
 
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Brand Name
ESPRIT VENTILATOR
Type of Device
VENTILATOR
Manufacturer (Section D)
PHILIPS HEALTHCARE / INNER COOL
6740 top gun street
san diego CA 92121
Manufacturer (Section G)
RICA
2271 cosmos court
carlsbad CA 92011
Manufacturer Contact
lisa cardenas
6740 top gun street
san diego, CA 92121
MDR Report Key8158445
MDR Text Key131384625
Report Number2032640-2018-00026
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 health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
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 Received11/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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