Definition: Non-alarming Software That Captures Patient Data From Patient Monitoring Devices And Transmits The Data To The Patient Electronic Medical Record, Where The Data Is Stored.
| Device Type ID | 2862 |
| Device Name | Software, Transmission And Storage, Patient Data |
| 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 | Contact ODE |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | NSX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2862 |
| Device | Software, Transmission And Storage, Patient Data |
| Product Code | NSX |
| Device Problems | |
|---|---|
Computer Software Problem | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Patient Data Problem | 1 |
Device Operates Differently Than Expected | 1 |
Electrical /Electronic Property Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 7 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BD LIFE SCIENCES | II | Apr-04-2017 |
| 2 | Soft Computer Consultants, Inc. | II | Aug-02-2017 |
| 3 | Soft Computer Consultants, Inc. | II | Jan-26-2017 |