MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-19 for OMNICELL manufactured by Omnicell, Inc..
[57880869]
Patient Sequence No: 1, Text Type: N, H10
[57880870]
Omnicell would not dispense norco in ed. This item is available in multiple omnicells. To address immediate patient issue, product could be obtained from other omnicell. The next day, am pharmacy checked and found no problem with hydrocodone. No hydrocodone was dispensed that day. That day, i verified the following: hydrocodone was cycle counted - count was correct. Coil containing hydrocodone was inspected and found to be intact. Hydrocodone was destocked and restocked and coil functioned as expected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6040502 |
| MDR Report Key | 6040502 |
| Date Received | 2016-10-19 |
| Date of Report | 2016-09-06 |
| Date of Event | 2015-11-14 |
| Report Date | 2015-11-24 |
| Date Reported to FDA | 2015-11-24 |
| Date Reported to Mfgr | 2015-11-24 |
| Date Added to Maude | 2016-10-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNICELL |
| Generic Name | MEDICAL COMPUTERS AND SOFTWARE |
| Product Code | LIB |
| Date Received | 2016-10-19 |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OMNICELL, INC. |
| Manufacturer Address | 590 E. MIDDLEFIELD ROAD MOUNTAIN VIEW CA 94043 US 94043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-19 |