Definition: A Medical Device Data System (mdds) Is A Device That Is Intended To Provide One Or More Of The Following Uses, Without Controlling Or Altering The Functions Or Parameters Of Any Connected Medical Devices: (i) The Electronic Transfer Of Medical Device
| Device Type ID | 2729 |
| Device Name | Medical Device Data System |
| Physical State | Software And Electronics |
| Technical Method | Software Algorithms To Perform Necessary Medical Communication Functions |
| Target Area | Hospital Information Systems |
| Regulation Description | Medical Device Data System. |
| 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 | 880.6310 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OUG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2729 |
| Device | Medical Device Data System |
| Product Code | OUG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Medical Device Data System. |
| CFR Regulation Number | 880.6310 [🔎] |
| Device Problems | |
|---|---|
Computer Software Problem | 404 |
Device Operates Differently Than Expected | 6 |
Data Problem | 5 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Application Program Problem: Parameter Calculation Error | 4 |
Device Operational Issue | 4 |
Problem With Software Installation | 2 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 2 |
Loss Of Data | 1 |
Improper Device Output | 1 |
Programming Issue | 1 |
Device Component Or Accessory | 1 |
Intermittent Communication Failure | 1 |
Connection Problem | 1 |
Disconnection | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Low Test Results | 1 |
Inadequate Or Insufficient Training | 1 |
Installation-Related Problem | 1 |
Patient Data Problem | 1 |
| Total Device Problems | 444 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | Dec-15-2016 |
| 2 | Beckman Coulter Inc. | II | Mar-28-2016 |
| 3 | Beckman Coulter Inc. | II | Sep-23-2015 |
| 4 | Horiba Instruments Inc | II | Dec-23-2014 |
| 5 | Intel-GE Care Innovations LLC | II | Jul-16-2018 |
| 6 | Maquet Medical Systems USA | II | Jan-16-2015 |
| 7 | Medtronic MiniMed Inc. | II | Oct-11-2018 |
| 8 | Merge Healthcare, Inc. | II | Mar-20-2017 |
| 9 | Merge Healthcare, Inc. | II | Nov-28-2016 |
| 10 | Philips Electronics North America Corporation | II | Jan-26-2017 |
| 11 | Philips Healthcare Informatics, Inc. | II | May-21-2014 |