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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 22
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 02/29/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). If more information becomes available a follow up will be submitted. (b)(4). The carefusion field service engineer (fse) was onsite and stated the arm was tight so when the customer adjusted the arm, it probably put pressure and loosened the screw. The fse tightened the arm and lubricated the joints which solved the reported issue. The fse repaired the impulse oscillatory spirometry (ios) arm and was returned to the customer. The device is currently working without issue.

 
Event Description

The customer reported the impulse oscillatory spirometry (ios) arm fell off. There was no patient involvement associated with this event. The carefusion field service engineer (fse) was scheduled to inspect the unit at the customer's facility.

 
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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
8473628056
MDR Report Key5527757
MDR Text Key41419862
Report Number2021710-2016-03378
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 02/29/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/25/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVMAX ENCORE 22
Device Catalogue Number777404-101
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/29/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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