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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 7
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 50
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
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 6
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 14
OBS MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
OMRON HEALTHCARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 68
SABRATEK
  SUBSTANTIALLY EQUIVALENT 1
SCHILLER
  SUBSTANTIALLY EQUIVALENT 3
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 12
SIEMENS
  SUBSTANTIALLY EQUIVALENT 14
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 11
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
WITT BIOMEDICAL CORP
  SUBSTANTIALLY EQUIVALENT 3
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device inoperable 788
Device operates differently than expected 162
No display or display failure 141
Device stops intermittently 79
Device alarm system issue 77
Wireless communication issue 73
Communication or transmission issue 67
Device displays error message 63
Not audible alarm 41
No Known Device Problem 28
No code available 25
Application interface becomes non-functional or program exits abnormally 25
No Information 23
Loss of power 19
Failure to power-up 18
Device Issue 17
Defective Alarm 13
Temperature issue 13
Failure to calibrate 12
Failure to service 12
Use of Device Issue 12
Improper alarm 10
Power source issue 7
Low audible alarm 7
Burn of device or device component 7
Delayed alarm 7
Alarm not visible 6
Incorrect or inadequate result 6
Device sensing issue 6
Failure to analyze rhythm 5
Component falling 5
Invalid sensing 5
Overheating of device or device component 5
Smoking 5
Radiofrequency interference (RFI) 5
Loss of Data 5
Use of Incorrect Control Settings 4
Calibration error 4
Incorrect interpretation of rhythm 4
Output issue 4
Patient Data Issue 4
Device handling issue 4
Device maintenance issue 3
Break 3
Detachment of device component 3
Battery issue 3
Computer operating system issue 3
No voice prompts 3
Defective component 3
Improper or incorrect procedure or method 2
Failure to sense 2
Telemetry discrepancy 2
Inadequate training 2
Connection issue 2
Spark 2
Disconnection 2
Melted 2
Image display error 2
False reading from device non-compliance 2
Noise, Audible 2
Data Issue 2
Operating system becomes non-functional 2
Medical Gas Supply problem 2
Naturally worn 1
No flow 1
Dislodged or dislocated 1
Improper device output 1
Misassembled by Users 1
Filling problem 1
Unintended ejection 1
Fluid leak 1
Loose or intermittent connection 1
False positive result 1
Device emits odor 1
No device output 1
Incorrect measurement 1
Self-activation or keying 1
Crack 1
Computer failure 1
Computer software issue 1
Charred 1
False alarm 1
Application network issue 1
Application program issue 1
Implant, removal of 1
Malfunction 1
Low test results 1
Low readings 1
Defective item 1
Parameter calculation error due to software problem 1
Inadequate service 1
Slippage of device or device component 1
Electro-static discharge 1
Component missing 1
Total Device Problems 1903

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 1 0 0 0 0 0 0
Class II 2 4 5 7 15 13 13 27 8 13 7
Class III 0 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 Draegar Medical Systems, Inc. II Jul-14-2017
4 Draegar Medical Systems, Inc. II Apr-10-2017
5 Draeger Medical Systems, Inc. II Jan-10-2014
6 Draeger Medical Systems, Inc. II Aug-22-2011
7 Draeger Medical Systems, Inc. II Aug-26-2010
8 Draeger Medical, Inc. II Mar-11-2013
9 Draeger Medical, Inc. II Nov-23-2011
10 Draeger Medical, Inc. I Nov-22-2011
11 Draeger Medical, Inc. II Dec-29-2009
12 Fukuda Denshi USA, Inc. II Jan-16-2016
13 GE Healthcare II May-12-2015
14 GE Healthcare II Jun-01-2009
15 GE Healthcare, LLC II Oct-09-2014
16 GE Healthcare, LLC II Jul-24-2014
17 GE Healthcare, LLC II Jul-21-2014
18 GE Healthcare, LLC II Mar-11-2014
19 GE Healthcare, LLC II Mar-06-2014
20 GE Healthcare, LLC II Feb-14-2014
21 GE Healthcare, LLC II Feb-04-2014
22 GE Healthcare, LLC II Jan-28-2014
23 GE Healthcare, LLC II Jan-22-2014
24 GE Healthcare, LLC II Jan-14-2014
25 GE Healthcare, LLC II Jan-09-2014
26 GE Healthcare, LLC II Dec-12-2013
27 GE Healthcare, LLC II Sep-19-2013
28 GE Healthcare, LLC II Sep-16-2013
29 GE Healthcare, LLC II Aug-28-2013
30 GE Healthcare, LLC II Jun-21-2013
31 GE Healthcare, LLC II Feb-14-2013
32 GE Healthcare, LLC II Feb-14-2013
33 GE Healthcare, LLC II Feb-13-2013
34 GE Healthcare, LLC II Dec-16-2012
35 GE Healthcare, LLC II Dec-14-2012
36 GE Healthcare, LLC II Jul-16-2012
37 GE Healthcare, LLC II Aug-25-2011
38 GE Healthcare, LLC II Apr-08-2011
39 GE Healthcare, LLC II Apr-08-2011
40 GE Healthcare, LLC II Mar-03-2011
41 GE Healthcare, LLC II Nov-15-2010
42 GE Healthcare, LLC II Nov-15-2010
43 GE Healthcare, LLC II Aug-25-2010
44 Ge Healthcare, Llc II Jun-11-2010
45 Mindray DS USA, Inc. d.b.a. Mindray North America II Dec-17-2012
46 Mindray DS USA, Inc. d.b.a. Mindray North America II Dec-11-2012
47 Mindray DS USA, Inc. d.b.a. Mindray North America II Aug-28-2012
48 Mindray DS USA, Inc. dba Mindray North America II Jun-27-2017
49 Mindray DS USA, Inc. dba Mindray North America II Oct-28-2016
50 Mindray DS USA, Inc. dba Mindray North America II Aug-16-2016
51 Mindray DS USA, Inc. dba Mindray North America II Apr-27-2016
52 Mindray DS USA, Inc. dba Mindray North America II Jan-29-2016
53 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2015
54 Mindray DS USA, Inc. dba Mindray North America II May-26-2015
55 Mindray DS USA, Inc. dba Mindray North America II Mar-16-2015
56 Mindray DS USA, Inc. dba Mindray North America II Dec-19-2014
57 Mindray DS USA, Inc. dba Mindray North America II Oct-21-2014
58 Mindray DS USA, Inc. dba Mindray North America II Jul-16-2014
59 Mindray DS USA, Inc. dba Mindray North America II May-13-2014
60 Mindray DS USA, Inc. dba Mindray North America II Mar-07-2014
61 Mindray DS USA, Inc. dba Mindray North America II Nov-25-2013
62 Mindray DS USA, Inc., dba Datascope Patient Monitoring II Jun-10-2010
63 Mindray DS USA, Inc., dba Datascope Patient Monitoring II May-27-2009
64 Mini-Mitter Company, Inc. II Jan-17-2008
65 Mortara Instrument, Inc II Oct-22-2014
66 Nihon Kohden America Inc II Mar-20-2017
67 Nihon Kohden America Inc II Apr-29-2015
68 Nihon Kohden America Inc II Jul-02-2014
69 Philips Electronics North America Corporation II Jun-13-2017
70 Philips Electronics North America Corporation II May-31-2017
71 Philips Electronics North America Corporation II Feb-22-2017
72 Philips Electronics North America Corporation II Oct-20-2016
73 Philips Electronics North America Corporation II Aug-03-2016
74 Philips Electronics North America Corporation II Feb-23-2016
75 Philips Electronics North America Corporation II Feb-23-2016
76 Philips Healthcare Inc. II Jun-11-2014
77 Philips Healthcare Inc. II Jul-20-2013
78 Philips Healthcare Inc. II Dec-10-2012
79 Philips Healthcare Inc. II Mar-01-2012
80 Philips Healthcare Inc. II Jun-17-2011
81 Philips Healthcare Inc. II May-19-2011
82 Philips Healthcare Inc. II Jan-27-2011
83 Philips Healthcare Inc. II Aug-10-2010
84 Philips Healthcare Inc. II Nov-23-2009
85 Philips Medical Systems II Sep-16-2008
86 Philips Medical Systems II Dec-11-2007
87 Philips Medical Systems II Sep-05-2007
88 Philips Medical Systems, Inc. II Dec-04-2015
89 Philips Medical Systems, Inc. II Oct-21-2014
90 Philips Medical Systems, Inc. II Jun-10-2014
91 Philips Medical Systems, Inc. II May-16-2014
92 Spacelabs Healthcare Inc II Nov-02-2016
93 Spacelabs Healthcare Inc II Sep-26-2016
94 Spacelabs Healthcare Inc II Aug-22-2016
95 Spacelabs Healthcare Inc II Mar-10-2016
96 Spacelabs Healthcare Inc II May-13-2015
97 Spacelabs Healthcare Inc II Feb-24-2015
98 Spacelabs Healthcare Inc II Sep-25-2014
99 Spacelabs Healthcare Inc II Sep-04-2014
100 Spacelabs Healthcare Inc II Jun-23-2014
101 Spacelabs Healthcare, Incorporated II Sep-11-2009
102 Spacelabs Healthcare, Llc II Jan-30-2014
103 Spacelabs Healthcare, Llc II Nov-18-2013
104 Spacelabs Healthcare, Llc II Nov-08-2013
105 Spacelabs Healthcare, Llc II Nov-20-2012
106 Spacelabs Healthcare, Llc II Nov-05-2012
107 Spacelabs Healthcare, Llc II Jul-16-2012
108 Spacelabs Healthcare, Llc II Jun-05-2012
109 Spacelabs Healthcare, Llc II Aug-18-2011
110 Spacelabs Healthcare, Llc II Aug-17-2011
111 Spacelabs Healthcare, Llc II Aug-15-2011
112 Spacelabs Healthcare, Llc II Aug-02-2011
113 Spacelabs Healthcare, Llc II Jun-20-2011
114 Spacelabs Healthcare, Llc II May-03-2011
115 Zoe Medical Incorporated II Sep-14-2012

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