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	42	42
Communication or Transmission Problem	12	12
Fail-Safe Problem	11	11
Delayed Alarm	3	3
Device Alarm System	3	3
Loose or Intermittent Connection	2	2
Appropriate Term/Code Not Available	2	2
False Alarm	1	1
Defective Alarm	1	1
Low Audible Alarm	1	1
Break	1	1
Disconnection	1	1
Device Slipped	1	1
Inappropriate Audible Prompt/Feedback	1	1
No Audible Prompt/Feedback	1	1
Loss of Power	1	1
Failure to Power Up	1	1
No Fail-Safe Mechanism	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Insufficient Information	1	1
Complete Loss of Power	1	1
Intermittent Loss of Power	1	1
Activation Problem	1	1
Key or Button Unresponsive/not Working	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	61	61
No Consequences Or Impact To Patient	11	11
Insufficient Information	5	5
Bone Fracture(s)	3	3
Fall	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Intracranial Hemorrhage	1	1
Laceration(s)	1	1
Limb Fracture	1	1
Bruise/Contusion	1	1