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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 VMAX ENCORE 29 UNIT ASSEM
Device Problem Device Stops Intermittently (1599)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/14/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). No device or parts will not be returned to carefusion for evaluation. The customer reran the protocol and the reported issue was not observed so the customer has stated they only want to document the issue and will not be returning the device for evaluation.

 
Event Description

The customer reported that trackmaster treadmill stopped fourteen minutes into the exercise phase using the modified mvo2 protocol. The device was in use on a patient at the time of the event; however, there was no injury to the patient. The customer later ran a mock test using the same protocol and the treadmill did not stop.

 
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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
MDR Report Key6097717
MDR Text Key60083620
Report Number2021710-2016-04833
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 RESPIRATORY THERAPIST
Type of Report Initial
Report Date 11/11/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/11/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVMAX ENCORE 29 UNIT ASSEM
Device Catalogue Number229C E
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 Received10/14/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured12/01/2010
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: 11/11/2016 Patient Sequence Number: 1
Treatment
TRKMSTR TRDMILL DOM 220V NO CNTRL, SN: (B)(4)
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