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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 3100B; VENTILATOR, HIGH FREQUENCY
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CAREFUSION 3100B; VENTILATOR, HIGH FREQUENCY Back to Search Results
Model Number SENMED/3100B
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Hypoxia (1918); Loss of consciousness (2418); Low Oxygen Saturation (2477)
Event Date 08/15/2015
Event Type  malfunction  
Event Description
The patient was placed on the oscillator; however, two days later, the patient began to desat and was not getting enough oxygen.The patient was sedated at this time and was not moving or breathing over the ventilator.The rt began troubleshooting to see if the problem was water in the tubes, etc., but it did not work.The machine had to be replaced as it would not maintain pressure.Manufacturer response for care fusion oscillator ventilator, care fusion oscillator ventilator (per site reporter): unknown.
 
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Brand Name
3100B
Type of Device
VENTILATOR, HIGH FREQUENCY
Manufacturer (Section D)
CAREFUSION
1100 bird center dr.
palm springs CA 92262
MDR Report Key5077164
MDR Text Key25778700
Report Number5077164
Device Sequence Number1
Product Code LSZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Patient
Type of Report Initial
Report Date 08/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberSENMED/3100B
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/26/2015
Event Location Hospital
Date Report to Manufacturer08/26/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
OSCILLATOR MALFUNCTION AND WAS NOT HOLDING PRESSUR
Patient Age15 YR
Patient Weight74
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