MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-06 for COPE SYSTEM manufactured by .
[21790357]
I recently noticed that the cope system in our facility may lead to selection errors in an unforseen way. Most providers will type in the first few letters of the drug name, then select the correct option from a drop down box. When searching for restoril using "restor", our system prompted selection for "rosuvastatin" as the brand name crestor contains restor. I tried several other drug name searches and similar misleading selections were prompted as well. I can send screen shots. In places that i have worked previously, search terms only yield results of drug names that begin with the first letter of the search term. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043990 |
| MDR Report Key | 4908695 |
| Date Received | 2015-07-06 |
| Date Added to Maude | 2015-07-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COPE SYSTEM |
| Generic Name | COPE SYSTEM |
| Product Code | NSX |
| Date Received | 2015-07-06 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-06 |