MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-28 for OMNICELL AUTOMATED DISPENSING CABINETS manufactured by Omnicell, Inc..
[81618017]
Door failure on omnicell automated dispensing cabinet. The access door is not locking when the door is shut allowing the medications in the cabinet to be accessed by simply pulling on the door. This is a major pt safety concern as well as a security concern. One of the main selling features of these omnicell machines is that they are secured so they do not have to be placed behind traditional locked doors in a medication room, but can be placed in a common area where only staff with allowed access can access the cabinet. This is not the case as now anyone who pulls on the malfunctioning door system can easily have access to whatever is contained inside the cabinet, including pts or anyone passing by the machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071306 |
| MDR Report Key | 6756473 |
| Date Received | 2017-07-28 |
| Date of Report | 2017-07-28 |
| Date of Event | 2017-07-27 |
| Date Added to Maude | 2017-08-01 |
| 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 | 3 |
| Reporter Occupation | PHARMACIST |
| 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 | 0 |
| Brand Name | OMNICELL AUTOMATED DISPENSING CABINETS |
| Generic Name | CABINETS, MEDICATIONS MANAGEMENT SYSTEM, REMOTE |
| Product Code | NZH |
| Date Received | 2017-07-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OMNICELL, INC. |
| Manufacturer Address | MOUNTAIN VIEW CA 94043 US 94043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-28 |