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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 207, INC. DBA CAREFUSION VMAX PFT MACHINE CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION

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CAREFUSION 207, INC. DBA CAREFUSION VMAX PFT MACHINE CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
Device Problems Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/28/2014
Event Type  Malfunction  
Event Description

The respiratory therapist was conducting a pulmonary function test (pft) on a patient when the arm of the pft machine fell off. Therapist grabbed the arm to prevent it from hitting the patient. The machine is less than a year old and this was an unexpected event. The manufacturer was notified.

 
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Brand NameVMAX PFT MACHINE
Type of DeviceCALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
Manufacturer (Section D)
CAREFUSION 207, INC. DBA CAREFUSION
22745 savi ranch parkway
yorba linda CA 92887
MDR Report Key5115625
MDR Text Key27213050
Report Number5115625
Device Sequence Number1
Product Code BTY
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 09/30/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/30/2015
Device Age1 yr
Event Location Hospital
Date Report TO Manufacturer09/30/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/01/2015 Patient Sequence Number: 1
Treatment
NO
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