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U.S. Department of Health and Human Services

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

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CAREFUSION STATIC AND DYNAMIC COMPLIANCE CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION Back to Search Results
Model Number 22 E
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 11/23/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The customer replaced the screw of the arm bracket which resolved the reported issue. The device is currently functioning without any further issues. The screws will be returned to carefusion for an evaluation. When we receive the results of the investigation a follow up will be submitted. Carefusion continues to track and trend any incident related to this issue. (b)(4).

 
Event Description

The customer reported that the arm of the pulmonary function testing (pft) machine fell off of the cart. He stated that the screws on the mounting bracket are stripped, got loose and fell off. The incident happened while testing a patient. The customer caught the arm as it was falling and there was no harm done to the patient.

 
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Brand NameSTATIC AND DYNAMIC COMPLIANCE
Type of DeviceCALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
Manufacturer (Section D)
CAREFUSION
22745 savi ranch parkway
yorba linda CA 92887
Manufacturer (Section G)
CAREFUSION
1100 bird center drive
palm springs CA 92262
Manufacturer Contact
jill rittorno
75 north fairway drive
vernon hills, IL 60061
8473628056
MDR Report Key5304348
MDR Text Key34329553
Report Number2021710-2015-02478
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 11/23/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/16/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number22 E
Device Catalogue Number777404-101
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 Received11/23/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/07/2014
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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