FDA.reportPublic FDA data

MAUDE MDR 6746508

MDR report key
6746508
Report number
MW5071263
Event key
0
Event type
3
Date received
2017-07-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OMNICELL CABINETOMNICELL DRUG DELIVERY CABINETUNKLNXI *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-250

Event Narratives#

D

Patient 1

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).