TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
AFRAME DIGITAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
CENTAURI MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTEL-GE CARE INNOVATIONS LLC
	SUBSTANTIALLY EQUIVALENT	1
LEAF HEALTHCARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
WIRELESS MEDCARE, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Alarm System	174	174
No Audible Alarm	118	118
Device Operates Differently Than Expected	28	28
Loose or Intermittent Connection	27	27
Loss of Power	18	18
Defective Alarm	16	16
Insufficient Information	16	16
Fitting Problem	15	15
Improper Alarm	15	15
Failure to Power Up	15	15
Break	14	14
False Alarm	13	13
Adverse Event Without Identified Device or Use Problem	12	12
Device Issue	12	12
Device Stops Intermittently	11	11
Delayed Alarm	10	10
Component Missing	8	8
Battery Problem	8	8
Device Displays Incorrect Message	8	8
Component Falling	7	7
Device Slipped	6	6
Communication or Transmission Problem	6	6
Device Inoperable	6	6
Device Operational Issue	6	6
Connection Problem	6	6
Inaudible or Unclear Audible Prompt/Feedback	5	5
Power Problem	5	5
Failure to Sense	5	5
Device Sensing Problem	5	5
Alarm Not Visible	4	4
Defective Device	4	4
Fail-Safe Problem	4	4
Appropriate Term/Code Not Available	3	3
Defective Component	3	3
Device Damaged Prior to Use	3	3
Improper or Incorrect Procedure or Method	3	3
Intermittent Continuity	3	3
Detachment Of Device Component	2	2
Device Emits Odor	2	2
Unstable	2	2
Mechanical Problem	2	2
No Audible Prompt/Feedback	2	2
Smoking	2	2
Patient Device Interaction Problem	2	2
Use of Device Problem	2	2
Biocompatibility	1	1
No Device Output	1	1
Disconnection	1	1
Noise, Audible	1	1
Overheating of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	164	164
No Known Impact Or Consequence To Patient	156	156
Fall	87	88
No Patient Involvement	84	84
No Clinical Signs, Symptoms or Conditions	65	65
Bone Fracture(s)	16	16
Insufficient Information	15	15
Not Applicable	10	10
Head Injury	7	7
Hip Fracture	6	6
Injury	6	6
No Information	5	5
Skin Tears	5	5
No Patient involvement	3	3
Hemorrhage/Bleeding	3	3
Pain	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Death	2	2
Bruise/Contusion	2	2
Pressure Sores	2	2
Hematoma	2	2
Abrasion	2	2
Hemorrhage, Subarachnoid	2	2
Contusion	2	2
Intracranial Hemorrhage	2	2
Laceration(s)	2	2
Ambulation Difficulties	1	1
Distress	1	1
Loss of consciousness	1	1
Facial Nerve Paralysis	1	1
Anxiety	1	1
Fluid Discharge	1	1
Peeling	1	1
Depression	1	1
Discomfort	1	1
Vomiting	1	1
Swelling	1	1
Foreign Body In Patient	1	1
Confusion/ Disorientation	1	1
Cardiac Arrest	1	1
Localized Skin Lesion	1	1
Blister	1	1
Blood Loss	1	1
Suture Abrasion	1	1
Unspecified Gastrointestinal Problem	1	1
No Code Available	1	1
Hypersensitivity/Allergic reaction	1	1
Superficial (First Degree) Burn	1	1
Fracture, Arm	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	AliMed Corporation	II	Apr-16-2010
2	Curbell Medical, Inc.	II	Aug-26-2014
3	Hill-Rom Inc.	II	Mar-22-2020
4	Intel-GE Care Innovations LLC	II	Feb-23-2013
5	RF Technologies, Inc.	II	Jun-26-2013
6	Richard Wolf Medical Instruments Corp.	II	Mar-03-2015
7	Stanley Security Solutions Inc	II	May-15-2019
8	Stanley Security Solutions, Inc.	II	Sep-28-2012
9	Stanley Security Solutions, Inc.	II	Apr-28-2012
10	Stanley Security Solutions, Inc.	II	Apr-27-2012
11	Stanley Security Solutions, Inc.	II	Mar-31-2011
12	Stanley Security Solutions, Inc.	II	Jul-01-2010
13	Sterilmed Inc	II	Jan-13-2009