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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
ADVANCED INSTRUMENTATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALERTWATCH LLC
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EDAN INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
FUKUDA DENSHI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
FUKUDA DENSHI USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
GENERAL ELECTRIC CO.
  SUBSTANTIALLY EQUIVALENT 4
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANIN MEDICAL SERVICES CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTELESENS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MID-LINK CONSULTING CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
MINDRAY NORTH AMERICA
  SUBSTANTIALLY EQUIVALENT 1
MORTARA
  SUBSTANTIALLY EQUIVALENT 4
MORTARA INSTRUMENT, INC.
  SUBSTANTIALLY EQUIVALENT 4
NIHON KOHDEN
  SUBSTANTIALLY EQUIVALENT 1
NIHON KOHDEN CORP.
  SUBSTANTIALLY EQUIVALENT 1
NORTH-VISION TECH. INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 14
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 7
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
  SUBSTANTIALLY EQUIVALENT 6
REMOTE DIAGNOSTIC TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 2
REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIOMEDICAL ELECTRONICS CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 5
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SOTERA WIRELESS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPACELABS HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
SPACELABS HEALTHCARE LTD.
  SUBSTANTIALLY EQUIVALENT 2
TECHMEDIC DEVELOPMENT INTERNATIONAL B.V.
  SUBSTANTIALLY EQUIVALENT 1
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MANUFACTURING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ZOLL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device Inoperable 810
Communication or Transmission Problem 252
No Display / Image 228
Device Operates Differently Than Expected 176
Device Alarm System 130
Device Stops Intermittently 99
Wireless Communication Problem 96
Device Component Or Accessory 90
No Audible Alarm 86
Output Problem 81
Application Program Problem 78
Device Displays Incorrect Message 75
Unintended Application Program Shut Down 72
Application Interface Becomes Non-Functional Or Program Exits Abnormally 67
Device Issue 67
Device Operational Issue 58
Power Problem 57
Protective Measures Problem 54
Display or Visual Feedback Problem 48
Defective Alarm 46
Appropriate Term/Code Not Available 42
Incorrect, Inadequate or Imprecise Result or Readings 40
Unexpected Shutdown 33
Speaker 32
Complete Loss of power 31
Adverse Event Without Identified Device or Use Problem 31
Loss of Power 29
Failure to Power Up 27
Electrical /Electronic Property Problem 27
Power Supply 24
Insufficient Information 24
Alarm Not Visible 22
Application Program Freezes, Becomes Nonfunctional 20
Use of Device Problem 19
No Device Output 19
Overheating of Device 18
Device Sensing Problem 18
Mechanical Problem 17
Thermal Decomposition of Device 17
Temperature Problem 16
Improper Alarm 16
Computer Software Problem 15
Failure To Service 15
Patient Data Problem 14
Alarm 14
Incorrect Interpretation of signal 13
Use of Incorrect Control Settings 13
Compatibility Problem 12
Failure to Calibrate 12
Incorrect Measurement 12
Invalid Sensing 12
Human Factors Issue 11
Monitor 10
Display 9
Low Readings 9
Human-Device Interface Problem 9
Data Problem 9
Failure to Analyze Signal 9
Delayed Alarm 8
Failure to Sense 7
Device Handling Problem 7
Smoking 7
Defective Component 7
Loose or Intermittent Connection 7
Loss of Data 6
No Audible Prompt / Feedback 6
Inappropriate or Unexpected Reset 6
Alarm, Volume 6
Patient Device Interaction Problem 6
Application Network Problem 6
Low Audible Alarm 6
Device Appears to Trigger Rejection 6
Erratic or Intermittent Display 5
Radiofrequency Interference (RFI) 5
Patient-Device Incompatibility 4
Application Program Problem: Parameter Calculation Error 4
False Alarm 4
Device Maintenance Issue 4
Cable 4
Computer Operating System Problem 4
Intermittent loss of power 4
Operating System Becomes Nonfunctional 4
Intermittent Communication Failure 4
Power Cord 4
Calibration Error 4
High Readings 4
Failure to Read Input Signal 3
Electrical Power Problem 3
Battery Problem 3
Improper Device Output 3
Screen 3
Break 3
Image Display Error / Artifact 3
Improper or Incorrect Procedure or Method 3
Circuit Failure 3
Off-Label Use 3
Unable to Obtain Readings 3
Display Difficult to Read 3
CPU (Central Processing Unit) Board 2
Noise, Audible 2
Total Device Problems 3579

Recalls
Manufacturer Recall Class Date Posted
1 Datascope Corp. II Nov-01-2019
2 Draegar Medical Systems, Inc. II Nov-14-2019
3 Draegar Medical Systems, Inc. II Oct-31-2019
4 Draegar Medical Systems, Inc. II Mar-05-2019
5 Draegar Medical Systems, Inc. II May-14-2018
6 Draegar Medical Systems, Inc. II Apr-16-2018
7 Draegar Medical Systems, Inc. II Mar-09-2018
8 Draegar Medical Systems, Inc. II Jul-14-2017
9 Draegar Medical Systems, Inc. II Apr-10-2017
10 Draeger Medical Systems, Inc. II Jan-10-2014
11 Edan Diagnostics II Oct-11-2018
12 Fukuda Denshi Co., Ltd. II Dec-06-2017
13 Fukuda Denshi USA, Inc. II Jan-16-2016
14 GE Healthcare II May-12-2015
15 GE Healthcare, LLC II Dec-07-2018
16 GE Healthcare, LLC II Nov-29-2018
17 GE Healthcare, LLC II Oct-09-2014
18 GE Healthcare, LLC II Jul-24-2014
19 GE Healthcare, LLC II Jul-21-2014
20 GE Healthcare, LLC II Mar-11-2014
21 GE Healthcare, LLC II Mar-06-2014
22 GE Healthcare, LLC II Feb-14-2014
23 GE Healthcare, LLC II Feb-04-2014
24 GE Healthcare, LLC II Jan-28-2014
25 GE Healthcare, LLC II Jan-22-2014
26 GE Healthcare, LLC II Jan-14-2014
27 GE Healthcare, LLC II Jan-09-2014
28 GE Medical Systems Information Technologies, Inc. II Dec-06-2017
29 Mindray DS USA, Inc. dba Mindray North America II Oct-17-2018
30 Mindray DS USA, Inc. dba Mindray North America II Jun-27-2017
31 Mindray DS USA, Inc. dba Mindray North America II Oct-28-2016
32 Mindray DS USA, Inc. dba Mindray North America II Aug-16-2016
33 Mindray DS USA, Inc. dba Mindray North America II Apr-27-2016
34 Mindray DS USA, Inc. dba Mindray North America II Jan-29-2016
35 Mindray DS USA, Inc. dba Mindray North America II Sep-04-2015
36 Mindray DS USA, Inc. dba Mindray North America II May-26-2015
37 Mindray DS USA, Inc. dba Mindray North America II Mar-16-2015
38 Mindray DS USA, Inc. dba Mindray North America II Dec-19-2014
39 Mindray DS USA, Inc. dba Mindray North America II Oct-21-2014
40 Mindray DS USA, Inc. dba Mindray North America II Jul-16-2014
41 Mindray DS USA, Inc. dba Mindray North America II May-13-2014
42 Mindray DS USA, Inc. dba Mindray North America II Mar-07-2014
43 Mortara Instrument, Inc II Oct-22-2014
44 Nihon Kohden America Inc II Mar-20-2017
45 Nihon Kohden America Inc II Apr-29-2015
46 Nihon Kohden America Inc II Jul-02-2014
47 Philips Electronics North America Corporation II Aug-22-2018
48 Philips Electronics North America Corporation II Apr-06-2018
49 Philips Electronics North America Corporation II Mar-03-2018
50 Philips Electronics North America Corporation II Feb-28-2018
51 Philips Electronics North America Corporation II Dec-27-2017
52 Philips Electronics North America Corporation III Dec-20-2017
53 Philips Electronics North America Corporation II Jun-13-2017
54 Philips Electronics North America Corporation II May-31-2017
55 Philips Electronics North America Corporation II Feb-22-2017
56 Philips Electronics North America Corporation II Oct-20-2016
57 Philips Electronics North America Corporation II Aug-03-2016
58 Philips Electronics North America Corporation II Feb-23-2016
59 Philips Electronics North America Corporation II Feb-23-2016
60 Philips Healthcare Inc. II Jun-11-2014
61 Philips Medical Systems, Inc. II Dec-04-2015
62 Philips Medical Systems, Inc. II Oct-21-2014
63 Philips Medical Systems, Inc. II Jun-10-2014
64 Philips Medical Systems, Inc. II May-16-2014
65 Philips North America, LLC II Sep-19-2019
66 Philips North America, LLC III Jun-12-2019
67 Philips North America, LLC II May-13-2019
68 Philips North America, LLC II Mar-28-2019
69 Spacelabs Healthcare Inc II Nov-02-2016
70 Spacelabs Healthcare Inc II Sep-26-2016
71 Spacelabs Healthcare Inc II Aug-22-2016
72 Spacelabs Healthcare Inc II Mar-10-2016
73 Spacelabs Healthcare Inc II May-13-2015
74 Spacelabs Healthcare Inc II Feb-24-2015
75 Spacelabs Healthcare Inc II Sep-25-2014
76 Spacelabs Healthcare Inc II Sep-04-2014
77 Spacelabs Healthcare Inc II Jun-23-2014
78 Spacelabs Healthcare, Llc II Jan-30-2014

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