| Device Type ID | 2624 |
| Device Name | Monitor, Bed Patient |
| 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 | KMI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2624 |
| Device | Monitor, Bed Patient |
| Product Code | KMI |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Bed-patient Monitor. |
| CFR Regulation Number | 880.2400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
LEAF HEALTHCARE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Alarm System | 44 |
No Audible Alarm | 25 |
Loose Or Intermittent Connection | 22 |
Improper Alarm | 14 |
Insufficient Information | 13 |
Device Issue | 12 |
False Alarm | 11 |
Adverse Event Without Identified Device Or Use Problem | 10 |
Fitting Problem | 10 |
Failure To Power Up | 7 |
Component Falling | 6 |
Device Stops Intermittently | 6 |
Device Operational Issue | 6 |
Inaudible Or Unclear Audible Prompt / Feedback | 5 |
Fail-Safe Problem | 4 |
Device Inoperable | 3 |
Alarm Not Visible | 3 |
Delayed Alarm | 3 |
Device Damaged Prior To Use | 3 |
Defective Alarm | 2 |
Mechanical Problem | 2 |
Communication Or Transmission Problem | 2 |
Device Operates Differently Than Expected | 2 |
Connection Problem | 2 |
Electrical /Electronic Property Problem | 1 |
Invalid Sensing | 1 |
Decreased Sensitivity | 1 |
Use Of Device Problem | 1 |
Unknown (for Use When The Device Problem Is Not Known) | 1 |
Component Missing | 1 |
Physical Property Issue | 1 |
Appropriate Term/Code Not Available | 1 |
Failure To Sense | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Battery Problem | 1 |
Incorrect Or Inadequate Test Results | 1 |
Low Audible Alarm | 1 |
Crack | 1 |
No Audible Prompt / Feedback | 1 |
Under-Sensing | 1 |
Detachment Of Device Component | 1 |
| Total Device Problems | 234 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Curbell Medical, Inc. | II | Aug-26-2014 |
| 2 | Richard Wolf Medical Instruments Corp. | II | Mar-03-2015 |