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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, physiological, patient(with arrhythmia detection or alarms)
Regulation Description Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Product CodeMHX
Regulation Number 870.1025
Device Class 2


Premarket Reviews
ManufacturerDecision
AGILENT TECHNIOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
ANALOGIC CORP.
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
Cardiopulmonary Corp.
  SUBSTANTIALLY EQUIVALENT 1
CAS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRITICARE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 5
DATEX-OHMEDA, INC.
  SUBSTANTIALLY EQUIVALENT 15
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 19
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 50
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
HEWLETT-PACKARD CO.
  SUBSTANTIALLY EQUIVALENT 5
HIDALGO LIMITED
  SUBSTANTIALLY EQUIVALENT 2
INVIVO
  SUBSTANTIALLY EQUIVALENT 3
IVY BIOMEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
LARSEN & TOUBRO LIMITED
  SUBSTANTIALLY EQUIVALENT 2
MEDIANA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MENNEN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MINDRAY
  SUBSTANTIALLY EQUIVALENT 2
MORTARA
  SUBSTANTIALLY EQUIVALENT 4
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 14
OBS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 63
SABRATEK
  SUBSTANTIALLY EQUIVALENT 1
SCHILLER
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 11
SIEMENS
  SUBSTANTIALLY EQUIVALENT 14
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 11
WITT BIOMEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 3
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device inoperable 588
Device alarm system issue 69
Device operates differently than expected 67
Device stops intermittently 58
Communication or transmission issue 42
No display or display failure 42
Device displays error message 39
Wireless communication issue 36
Not audible alarm 32
No code available 22
No Information 21
No Known Device Problem 20
Failure to calibrate 12
Failure to service 11
Use of Device Issue 10
Low audible alarm 7
Loss of power 7
Temperature issue 6
Smoking 5
Application interface becomes non-functional or program exits abnormally 4
Incorrect or inadequate result 4
Defective Alarm 4
Component falling 4
Delayed alarm 4
Use of Incorrect Control Settings 4
Patient Data Issue 4
Device handling issue 3
Incorrect interpretation of rhythm 3
Detachment of device component 3
No voice prompts 3
Break 3
Output issue 3
Battery issue 3
Radiofrequency interference (RFI) 3
Loss of Data 2
Medical Gas Supply problem 2
Power source issue 2
Data Issue 2
Defective component 2
Connection issue 2
Noise, Audible 2
Failure to analyze rhythm 2
Disconnection 2
Device maintenance issue 2
Inadequate training 2
Computer operating system issue 2
Failure to power-up 2
Low test results 1
Image display error 1
Loose or intermittent connection 1
Computer software issue 1
Calibration error 1
Malfunction 1
Crack 1
Filling problem 1
Fluid leak 1
Overheating of device or device component 1
Slippage of device or device component 1
Implant, removal of 1
Defective item 1
Naturally worn 1
Self-activation or keying 1
Inadequate service 1
Invalid sensing 1
Melted 1
Component missing 1
No flow 1
Low readings 1
Improper or incorrect procedure or method 1
Electro-static discharge 1
False alarm 1
Device sensing issue 1
Computer failure 1
False positive result 1
False reading from device non-compliance 1
Operating system becomes non-functional 1
Total Device Problems 1201

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 1 0 0 0 0 0
Class II 2 4 5 7 15 13 13 27 8 6
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 CAS Medical Systems, Inc. II Sep-16-2008
2 Datascope Corporation II Jan-17-2008
3 Draeger Medical Systems, Inc. II Jan-10-2014
4 Draeger Medical Systems, Inc. II Aug-22-2011
5 Draeger Medical Systems, Inc. II Aug-26-2010
6 Draeger Medical, Inc. II Mar-11-2013
7 Draeger Medical, Inc. II Nov-23-2011
8 Draeger Medical, Inc. I Nov-22-2011
9 Draeger Medical, Inc. II Dec-29-2009
10 Fukuda Denshi USA, Inc. II Jan-16-2016
11 GE Healthcare II May-12-2015
12 GE Healthcare II Jun-01-2009
13 GE Healthcare, LLC II Oct-09-2014
14 GE Healthcare, LLC II Jul-24-2014
15 GE Healthcare, LLC II Jul-21-2014
16 GE Healthcare, LLC II Mar-11-2014
17 GE Healthcare, LLC II Mar-06-2014
18 GE Healthcare, LLC II Feb-14-2014
19 GE Healthcare, LLC II Feb-04-2014
20 GE Healthcare, LLC II Jan-28-2014
21 GE Healthcare, LLC II Jan-22-2014
22 GE Healthcare, LLC II Jan-14-2014
23 GE Healthcare, LLC II Jan-09-2014
24 GE Healthcare, LLC II Dec-12-2013
25 GE Healthcare, LLC II Sep-19-2013
26 GE Healthcare, LLC II Sep-16-2013
27 GE Healthcare, LLC II Aug-28-2013
28 GE Healthcare, LLC II Jun-21-2013
29 GE Healthcare, LLC II Feb-14-2013
30 GE Healthcare, LLC II Feb-14-2013
31 GE Healthcare, LLC II Feb-13-2013
32 GE Healthcare, LLC II Dec-16-2012
33 GE Healthcare, LLC II Dec-14-2012
34 GE Healthcare, LLC II Jul-16-2012
35 GE Healthcare, LLC II Aug-25-2011
36 GE Healthcare, LLC II Apr-08-2011
37 GE Healthcare, LLC II Apr-08-2011
38 GE Healthcare, LLC II Mar-03-2011
39 GE Healthcare, LLC II Nov-15-2010
40 GE Healthcare, LLC II Nov-15-2010
41 GE Healthcare, LLC II Aug-25-2010
42 Ge Healthcare, Llc II Jun-11-2010
43 Mindray DS USA, Inc. d.b.a. Mindray North America II Dec-17-2012
44 Mindray DS USA, Inc. d.b.a. Mindray North America II Dec-11-2012
45 Mindray DS USA, Inc. d.b.a. Mindray North America II Aug-28-2012
46 Mindray DS USA, Inc. dba Mindray North America II Apr-27-2016
47 Mindray DS USA, Inc. dba Mindray North America II Jan-29-2016
48 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2015
49 Mindray DS USA, Inc. dba Mindray North America II May-26-2015
50 Mindray DS USA, Inc. dba Mindray North America II Mar-16-2015
51 Mindray DS USA, Inc. dba Mindray North America II Dec-19-2014
52 Mindray DS USA, Inc. dba Mindray North America II Oct-21-2014
53 Mindray DS USA, Inc. dba Mindray North America II Jul-16-2014
54 Mindray DS USA, Inc. dba Mindray North America II May-13-2014
55 Mindray DS USA, Inc. dba Mindray North America II Mar-07-2014
56 Mindray DS USA, Inc. dba Mindray North America II Nov-25-2013
57 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Jun-10-2010
58 Mindray DS USA, Inc., dba Datascope Patient Monitoring II May-27-2009
59 Mini-Mitter Company, Inc. II Jan-17-2008
60 Mortara Instrument, Inc II Oct-22-2014
61 Nihon Kohden America Inc II Apr-29-2015
62 Nihon Kohden America Inc II Jul-02-2014
63 Philips Electronics North America Corporation II Feb-23-2016
64 Philips Electronics North America Corporation II Feb-23-2016
65 Philips Healthcare Inc. II Jun-11-2014
66 Philips Healthcare Inc. II Jul-20-2013
67 Philips Healthcare Inc. II Dec-10-2012
68 Philips Healthcare Inc. II Mar-01-2012
69 Philips Healthcare Inc. II Jun-17-2011
70 Philips Healthcare Inc. II May-19-2011
71 Philips Healthcare Inc. II Jan-27-2011
72 Philips Healthcare Inc. II Aug-10-2010
73 Philips Healthcare Inc. II Nov-23-2009
74 Philips Medical Systems II Sep-16-2008
75 Philips Medical Systems II Dec-11-2007
76 Philips Medical Systems II Sep-05-2007
77 Philips Medical Systems, Inc. II Dec-04-2015
78 Philips Medical Systems, Inc. II Oct-21-2014
79 Philips Medical Systems, Inc. II Jun-10-2014
80 Philips Medical Systems, Inc. II May-16-2014
81 Spacelabs Healthcare Inc II Mar-10-2016
82 Spacelabs Healthcare Inc II May-13-2015
83 Spacelabs Healthcare Inc II Feb-24-2015
84 Spacelabs Healthcare Inc II Sep-25-2014
85 Spacelabs Healthcare Inc II Sep-04-2014
86 Spacelabs Healthcare Inc II Jun-23-2014
87 Spacelabs Healthcare, Incorporated II Sep-11-2009
88 Spacelabs Healthcare, Llc II Jan-30-2014
89 Spacelabs Healthcare, Llc II Nov-18-2013
90 Spacelabs Healthcare, Llc II Nov-08-2013
91 Spacelabs Healthcare, Llc II Nov-20-2012
92 Spacelabs Healthcare, Llc II Nov-05-2012
93 Spacelabs Healthcare, Llc II Jul-16-2012
94 Spacelabs Healthcare, Llc II Jun-05-2012
95 Spacelabs Healthcare, Llc II Aug-18-2011
96 Spacelabs Healthcare, Llc II Aug-17-2011
97 Spacelabs Healthcare, Llc II Aug-15-2011
98 Spacelabs Healthcare, Llc II Aug-02-2011
99 Spacelabs Healthcare, Llc II Jun-20-2011
100 Spacelabs Healthcare, Llc II May-03-2011
101 Zoe Medical Incorporated II Sep-14-2012

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