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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION VITAL SIGNS VITAL SIGNS STYLETTE
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CAREFUSION VITAL SIGNS VITAL SIGNS STYLETTE Back to Search Results
Model Number S1000NEU
Device Problems Bent (1059); Difficult to Insert (1316); Structural Problem (2506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/02/2013
Event Type  No Answer Provided  
Event Description
The customer has had multiple incidents in the last five months were unexpected difficulties in airway management has occurred.The problem is that the s1000neu is too soft and loses the desired shape when used in difficult airway management (intubation) situations.There is no report of pt injuries, but this reported as a pt concern with the potential for death or injury.
 
Manufacturer Narrative
Carefusion acquired ge vital signs on 12/31/2013.A retrospective review of all complaints post-acquisition was performed.This complaint was identified as meeting the qualifications for mdr reportability by cfn standards and is being submitted to the fda.
 
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Brand Name
VITAL SIGNS STYLETTE
Type of Device
STYLETTE
Manufacturer (Section D)
CAREFUSION VITAL SIGNS
11039 east lansing cir.
englewood CO 80112
Manufacturer Contact
jill rittorno
75 fairway dr
vernan hills, IL 80112-6006
8473628056
MDR Report Key3836274
MDR Text Key4453988
Report Number1718887-2014-00001
Device Sequence Number1
Product Code BSR
Combination Product (y/n)N
Reporter Country CodeDA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 01/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberS1000NEU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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