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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION VITAL SIGNS; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
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CAREFUSION VITAL SIGNS; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) Back to Search Results
Lot Number 0001189010
Device Problems Product Quality Problem (1506); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 01/16/2018
Event Type  malfunction  
Event Description
When preparing and setting up anesthesia breathing circuit for next case, it was noted that the co2 nipple attachment on the elbow of the adult breathing circuit did not have a hole in it for flow and monitoring.It is closed, no opening.Therefore, device would not function properly for anesthesia if needed to use.All of the said lot number have been pulled from stock.
 
Manufacturer Narrative
The following elements have blank data.
 
Event Description
When preparing and setting up anesthesia breathing circuit for next case, it was noted that the co2 nipple attachment on the elbow of the adult breathing circuit did not have a hole in it for flow and monitoring.It is closed, no opening.Therefore, device would not function properly for anesthesia if needed to use.All of the said lot number have been pulled from stock.
 
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Brand Name
VITAL SIGNS
Type of Device
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Manufacturer (Section D)
CAREFUSION
1100 bird center dr.
palm springs CA 92262
MDR Report Key7365524
MDR Text Key103311050
Report Number7365524
Device Sequence Number1
Product Code DSA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 01/24/2018,03/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2018
Is this a Product Problem Report? Yes
Device Operator No Information
Device Lot Number0001189010
Other Device ID NumberA46X29XX
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/24/2018
Event Location Hospital
Date Report to Manufacturer01/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NO; NO; NO; NO
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