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TPLC
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show TPLC since
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Device
system, monitoring, perinatal
Product Code
HGM
Regulation Number
884.2740
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADVANCED INSTRUMENTATIONS, INC.
SUBSTANTIALLY EQUIVALENT
4
AIRSTRIP TECHNOLOGIES, LP
SUBSTANTIALLY EQUIVALENT
2
ALERTWATCH, INC.
SUBSTANTIALLY EQUIVALENT
1
BISTOS CO., LTD.
SUBSTANTIALLY EQUIVALENT
4
BLOOM TECHNOLOGIES NV
SUBSTANTIALLY EQUIVALENT
1
CERNER CORP.
SUBSTANTIALLY EQUIVALENT
2
CIVNET COMMUNICATION LTD
SUBSTANTIALLY EQUIVALENT
1
CLINICAL COMPUTER SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
DATEX OHMEDA
SUBSTANTIALLY EQUIVALENT
1
EDAN INSTRUMENTS INC
SUBSTANTIALLY EQUIVALENT
1
EDAN INSTRUMENTS, INC
SUBSTANTIALLY EQUIVALENT
1
EDAN INSTRUMENTS, INC.
SUBSTANTIALLY EQUIVALENT
5
FARUS, LLC
SUBSTANTIALLY EQUIVALENT
1
GE HEALTHCARE INTEGRATED IT SOLUTIONS
SUBSTANTIALLY EQUIVALENT
1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
1
GUANGDONG BIOLIGHT MEDITECH CO., LTD
SUBSTANTIALLY EQUIVALENT
1
GUANGDONG BIOLIGHT MEDITECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
HUNTLEIGH HEALTHCARE LIMITED
SUBSTANTIALLY EQUIVALENT
2
HUNTLEIGH HEALTHCARE LTD.
SUBSTANTIALLY EQUIVALENT
1
MCKESSON INFORMATION SOLUTIONS LLC
SUBSTANTIALLY EQUIVALENT
1
MEDIANA CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MINDCHILD MEDICAL
SUBSTANTIALLY EQUIVALENT
3
OB TOOLS, LTD.
SUBSTANTIALLY EQUIVALENT
1
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH
SUBSTANTIALLY EQUIVALENT
2
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
SUBSTANTIALLY EQUIVALENT
3
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN
SUBSTANTIALLY EQUIVALENT
1
SENSE4BABY, INC.
SUBSTANTIALLY EQUIVALENT
1
SUNRAY MEDICAL APPARATUS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
WIPRO GE HEALTHCARE PRIVATE, LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
29
29
2015
44
44
2016
17
17
2017
27
27
2018
30
30
2019
41
41
2020
19
19
2021
71
71
2022
87
87
2023
69
69
2024
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Audible Prompt/Feedback
82
82
No Audible Alarm
66
66
Device Operates Differently Than Expected
42
42
Adverse Event Without Identified Device or Use Problem
33
33
Insufficient Information
24
24
Material Integrity Problem
19
19
Defective Alarm
19
19
Device Alarm System
17
17
Incorrect Measurement
17
17
No Apparent Adverse Event
16
16
Defective Device
13
13
Incorrect, Inadequate or Imprecise Result or Readings
12
12
Noise, Audible
8
8
Electrical /Electronic Property Problem
7
7
Crack
6
6
Unable to Obtain Readings
6
6
Incorrect Or Inadequate Test Results
6
6
Failure to Advance
5
5
Output Problem
5
5
Protective Measures Problem
5
5
Appropriate Term/Code Not Available
4
4
Audible Prompt/Feedback Problem
4
4
Device Displays Incorrect Message
4
4
Failure to Transmit Record
4
4
Use of Device Problem
4
4
Improper or Incorrect Procedure or Method
4
4
Component Falling
4
4
Circuit Failure
4
4
Overheating of Device
4
4
No Device Output
3
3
Erratic or Intermittent Display
3
3
Invalid Sensing
3
3
Failure to Sense
3
3
Communication or Transmission Problem
3
3
Device Inoperable
3
3
High Readings
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Electrical Shorting
3
3
Device Sensing Problem
2
2
Improper Device Output
2
2
Operating System Becomes Nonfunctional
2
2
Patient Device Interaction Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Connection Problem
2
2
Patient-Device Incompatibility
2
2
Incorrect Interpretation of Signal
2
2
Out-Of-Box Failure
2
2
Detachment Of Device Component
2
2
Signal Artifact/Noise
2
2
False Alarm
2
2
Break
2
2
Loss of Power
2
2
Fire
2
2
Image Display Error/Artifact
2
2
Imprecision
1
1
Loose or Intermittent Connection
1
1
Inaccurate Flow Rate
1
1
Poor Quality Image
1
1
Device Emits Odor
1
1
Energy Output Problem
1
1
Failure to Power Up
1
1
Product Quality Problem
1
1
Over-Sensing
1
1
Pitted
1
1
Power Conditioning Problem
1
1
Low Audible Alarm
1
1
Loss of or Failure to Bond
1
1
Display or Visual Feedback Problem
1
1
False Device Output
1
1
False Positive Result
1
1
Computer Software Problem
1
1
Disconnection
1
1
Radiofrequency Interference (RFI)
1
1
Device Contamination with Body Fluid
1
1
Material Perforation
1
1
Inappropriate Audible Prompt/Feedback
1
1
Self-Activation or Keying
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Smoking
1
1
Device Stops Intermittently
1
1
Application Network Problem
1
1
Application Program Problem
1
1
Calibration Problem
1
1
Loss of Data
1
1
Detachment of Device or Device Component
1
1
Low Readings
1
1
High Test Results
1
1
Inaudible or Unclear Audible Prompt/Feedback
1
1
Misassembly by Users
1
1
Device Fell
1
1
Unintended Electrical Shock
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Intermittent Communication Failure
1
1
Failure to Clean Adequately
1
1
Missing Information
1
1
Erratic Results
1
1
Scratched Material
1
1
Patient Data Problem
1
1
Device Handling Problem
1
1
Infusion or Flow Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
194
194
No Known Impact Or Consequence To Patient
42
42
Death
38
38
Insufficient Information
27
27
No Patient Involvement
21
21
No Consequences Or Impact To Patient
19
19
Fetal Distress
12
12
Death, Intrauterine Fetal
10
10
Not Applicable
10
10
No Information
7
7
Burn(s)
7
7
Injury
6
6
No Code Available
5
5
Cardiac Arrest
5
5
Bradycardia
5
5
Erythema
5
5
Skin Burning Sensation
4
4
Superficial (First Degree) Burn
3
3
Patient Problem/Medical Problem
3
3
Misdiagnosis
3
3
Burn, Thermal
3
3
Loss Of Pulse
3
3
Hypoxia
3
3
Encephalopathy
3
3
Inflammation
2
2
Tissue Damage
2
2
Hypoxia in Utero
2
2
Brain Injury
2
2
Low Oxygen Saturation
2
2
Complaint, Ill-Defined
2
2
Asystole
2
2
Partial thickness (Second Degree) Burn
2
2
Unspecified Respiratory Problem
1
1
Unspecified Reproductive System or Breast Problem
1
1
Valve Thrombosis
1
1
Loss of consciousness
1
1
Skin Tears
1
1
Anxiety
1
1
Asphyxia
1
1
Ischemia
1
1
Neurological Deficit/Dysfunction
1
1
Rash
1
1
Respiratory Distress
1
1
Skin Erosion
1
1
Skin Irritation
1
1
Tachycardia
1
1
Therapeutic Effects, Unexpected
1
1
Decreased Apgar
1
1
Non specific EKG/ECG Changes
1
1
Bone Fracture(s)
1
1
Head Injury
1
1
Hemorrhage/Bleeding
1
1
Cardiopulmonary Arrest
1
1
Cyanosis
1
1
Abnormal Blood Gases
1
1
Abrasion
1
1
Low Apgar Score
1
1
Arrhythmia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
GE Healthcare It
II
Nov-18-2013
2
Pacific Medical Group Inc.
II
Feb-04-2020
3
Philips Healthcare Inc.
II
Dec-17-2009
4
Philips Healthcare Inc.
II
Jun-26-2009
5
Philips Medical Systems, Inc.
II
Oct-21-2014
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