TPLC - Total Product Life Cycle

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Device	fall prevention alarm/sensor combination attached or unattached
Regulation Description	Bed-patient monitor.
Definition	The fall-prevention alarm/sensor is a combination device that can attach to a person usually by a clip or belt OR it can be used unattached to the person, where the person sits upon it.
Product Code	PJO
Regulation Number	880.2400
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Audible Alarm	50	50
Communication or Transmission Problem	32	32
Fail-Safe Problem	22	22
No Audible Prompt/Feedback	6	6
Device Alarm System	4	4
Delayed Alarm	3	3
Insufficient Information	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Appropriate Term/Code Not Available	2	2
Loose or Intermittent Connection	2	2
Disconnection	1	1
Device Slipped	1	1
Break	1	1
Activation Problem	1	1
No Fail-Safe Mechanism	1	1
Key or Button Unresponsive/not Working	1	1
Failure to Power Up	1	1
False Alarm	1	1
Defective Alarm	1	1
Low Audible Alarm	1	1
Complete Loss of Power	1	1
Loss of Power	1	1
Inappropriate Audible Prompt/Feedback	1	1
Intermittent Loss of Power	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	60	60
No Consequences Or Impact To Patient	50	50
Fall	7	7
Insufficient Information	5	5
Bone Fracture(s)	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Known Impact Or Consequence To Patient	1	1
Intracranial Hemorrhage	1	1
Injury	1	1
Foreign Body In Patient	1	1
Laceration(s)	1	1
Limb Fracture	1	1
Bruise/Contusion	1	1