FDA Adverse Event Other Summary report: N

OLYMPUS MOBILE WORKSTATION

MDR report key: 1530959 · Received October 21, 2009

Report

Report Number
9611174-2009-00004
Event Type
Other
Date Received
October 21, 2009
Report Date
September 22, 2009
Manufacturer
KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
Product Code
FET
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
PA, US
Reporter Occupation
NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE CART REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. OLYMPUS FOLLOWED UP ON THIS REPORT TO GATHER ADD'L INFO, AND THE USER FACILITY REPORTED THAT THE EMPLOYEE EXPERIENCED AN UNSPECIFIED TYPE OF INJURY ON HER SHOULDER AND NECK, AND WAS ON MEDICAL LEAVE FOR AN UNSPECIFIED TIME. THE EMPLOYEE HAS RETURNED TO WORK AND IS REPORTEDLY DOING WELL. THE CART IN QUESTION HAS NOT BEEN TAKEN OUT OF SERVICE. THE EXACT CAUSE OF THE EMPLOYEE'S OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THE USER FACILITY REPORTED THAT THE DEVICE WAS LADEN WITH MANY PIECES OF EQUIPMENT AT THE TIME OF THE EVENT, AND WAS SAID TO BE QUITE HEAVY. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

Description of Event or Problem · 1

OLYMPUS WAS INFORMED BY THE USER FACILITY THAT AN EMPLOYEE ALLEGEDLY BECAME INJURED WHILE PUSHING THE CART INTO THE ELEVATOR. THE CART WHEEL MAY HAVE BECOME CAUGHT IN A LARGE GAP WHERE THE FACILITY'S ELEVATOR MEETS THE FLOOR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 OLYMPUS MOBILE WORKSTATION CART FET KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. WM-NP1 NA

Patients

Seq Age Sex Outcome Treatment
1