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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC STATIC AND DYNAMIC COMPLIANCE CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

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CAREFUSION, INC STATIC AND DYNAMIC COMPLIANCE CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
Model Number 62 JAEGER
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/01/2016
Event Type  Injury  
Manufacturer Narrative

(b)(4). A replacement arm assembly was sent to the customer to resolve the issue. The customer stated no parts will be returned, therefore no investigation can be performed.

 
Event Description

The customer reported while using the static and dynamic compliance; the arm inside the body box broke due to the patient momentarily passed out during the procedure. The customer reported the patient slid from the seat while holding the arm inside the body box thus breaking it. The customer stated the device was used on a patient for pulmonary function testing at the time of the event. However, there was no patient impact associated with this event. There was no allegation of the unit or arm malfunctioning.

 
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Brand NameSTATIC AND DYNAMIC COMPLIANCE
Type of DeviceCALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
Manufacturer (Section D)
CAREFUSION, INC
22745 savi ranch parkway
yorba linda CA 92887
Manufacturer (Section G)
CAREFUSION, INC
1100 bird center dr.
palm springs CA 92262
Manufacturer Contact
jill rittorno
22745 savi ranch parkway
yorba linda, CA 92887
7149227830
MDR Report Key5956422
MDR Text Key54925846
Report Number2021710-2016-04452
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK981366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 09/01/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/16/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number62 JAEGER
Device Catalogue Number773835-101
Device LOT NumberSMI002762-A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/01/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 09/16/2016 Patient Sequence Number: 1
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