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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION FLEXIBLE PATIENT CIRCUIT KIT FOR 3100B HFOV; CAP/DIAPHRAGM SET
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CAREFUSION FLEXIBLE PATIENT CIRCUIT KIT FOR 3100B HFOV; CAP/DIAPHRAGM SET Back to Search Results
Device Problems Disconnection (1171); Loss of Power (1475)
Patient Problem No Information (3190)
Event Date 02/02/2014
Event Type  No Answer Provided  
Event Description
Pt was on the oscillator and a portable chest x-ray had just been taken.The x-ray cassette was removed and the oscillator alarmed and the machine turned off.The oscillator was not hit with the x-ray cassette.The dump/red diaphragm was disconnected from caused the hfov to shut off, cannot be determined.The respiratory therapist replaced the dump diaphragm and the vent began to function again.The flexible pt circuit kit is a kit that we have in stock.As we do not have the circuit kit involved with the event, we do not know the lot or model number.The circuit kit was inadvertently thrown away.Only the diaphragm cap was kept.Diagnostic tests were conducted by our biomed and there were no problems found.The oscillator is a rental unit from (b)(4) and (b)(4) has taken the oscillator.
 
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Brand Name
FLEXIBLE PATIENT CIRCUIT KIT FOR 3100B HFOV
Type of Device
CAP/DIAPHRAGM SET
Manufacturer (Section D)
CAREFUSION
2275 savi ranch parkway
yorba linda CA 92887 466
MDR Report Key3660841
MDR Text Key4317010
Report NumberMW5034795
Device Sequence Number1
Product Code LSZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/11/2014
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 Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/27/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age74 YR
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