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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device medical device data system
Regulation Description Medical device data system.
Definition A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; Or (iv) the electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring.
Product CodeOUG
Regulation Number 880.6310
Device Class 1

Device Problems
Computer software issue 8
Device operates differently than expected 6
Parameter calculation error due to software problem 4
No Known Device Problem 4
Data Issue 4
Communication or transmission issue 3
Application interface becomes non-functional or program exits abnormally 2
Patient Data Issue 2
Installation-related problem 2
Programming issue 2
Protective measure issue 1
No code available 1
Disconnection 1
Failure to transmit record 1
Low test results 1
Connection issue 1
Loss of Data 1
Improper device output 1
Total Device Problems 45

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 2 2 2 2 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II Mar-28-2016
2 Beckman Coulter Inc. II Sep-23-2015
3 CareFusion 209 Inc. II Jan-13-2012
4 Horiba Instruments Inc II Dec-23-2014
5 Maquet Cardiovascular Us Sales, Llc II Sep-25-2013
6 Maquet Medical Systems USA II Jan-16-2015
7 Medical Information Technology, Inc. II May-22-2013
8 Philips Healthcare Inc. II Jul-05-2012
9 Philips Healthcare Informatics, Inc. II May-21-2014

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