MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-25 for OMNICELL CABINET manufactured by Unk.
[81377469]
Omnicell cabinet was found with unsecure door. Door would open without having a user logged into it. Manual lock was locked. A total of 5 unsecure doors were found upon inspection of all cabinets in facility. A ticket was put into omnicell and tech fixed issue causing door to be unsecure. There is no notification that door is unsecure and random person can pull on door. Severity: circumstances or events have capacity to cause error. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071263 |
| MDR Report Key | 6746508 |
| Date Received | 2017-07-25 |
| Date of Report | 2017-04-21 |
| Date Added to Maude | 2017-07-27 |
| 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 |
| 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 CABINET |
| Generic Name | OMNICELL DRUG DELIVERY CABINET |
| Product Code | LNX |
| Date Received | 2017-07-25 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-25 |