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.
| Device Type ID | 2744 |
| Device Name | Fall Prevention Alarm/sensor Combination Attached Or Unattached |
| Physical State | This Fall Prevention Alarm Can Be Used Two Way. It Can Attach To A Person's Body Or Clothing Or It Can Be Used Unattached Where The Person Sits Upon The Sensor Pad As With Devices Cleared Under Product Code KMI. |
| Technical Method | The Alarm Activates When Weight Is Applied To The Sensor Changes Or The Magnet Clip Disconnects From The Alarm. This Alarm May Be Connected To The Nurse Call System. If The Alarm Is Connected To The Hospital's Nurse Call System, The Nurse Call Statio |
| Target Area | Device Can Be Used Two Different Ways: 1) Attached To The Person Or 2) Not Attached To The Person. If Used Attached To The Person, It Can Be Applied To A Person's Clothing By Use Of The Clip Or It Is Worn Around A Person's Waist Via The Belt. It Is N |
| Regulation Description | Bed-patient Monitor. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.2400 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PJO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2744 |
| Device | Fall Prevention Alarm/sensor Combination Attached Or Unattached |
| Product Code | PJO |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Bed-patient Monitor. |
| CFR Regulation Number | 880.2400 [🔎] |
| Device Problems | |
|---|---|
Communication Or Transmission Problem | 33 |
No Audible Alarm | 32 |
Fail-Safe Problem | 12 |
Unclear Information | 7 |
No Audible Prompt / Feedback | 3 |
Failure To Power Up | 2 |
Low Battery | 1 |
Device Alarm System | 1 |
Loose Or Intermittent Connection | 1 |
Low Audible Alarm | 1 |
Mechanical Problem | 1 |
Failure To Shut Off | 1 |
| Total Device Problems | 95 |