MAUDE MDR 3232378

MDR report key
3232378
Report number
3232378
Event key
0
Event type
3
Date of event
2013-07-05
Date received
2013-07-16
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
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ECHOBED DUALTABLE, EXAMINATION, MEDICAL, POWEREDMEDICAL POSITIONING, INCLGX1222** Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-07-160

Event Narratives#

D

Patient 1

THE PATIENT COMPLETED HER ECHOCARDIOGRAM AND WHILE SITTING UP SHE SCRAPED THE BACK OF HER RIGHT LEG WHILE PREPARING TO MOVE FROM THE ECHO BED BACK TO HER WHEEL CHAIR. PATIENT STATED THAT SHE HIT HER LEG. FLUID CONTAINING BLOOD WAS SEEN DRIPPING FROM HER UPPER CALF. PATIENT SCRAPED BACK OF HER LEG ON SMALL "POLE HOLDER" LOCATED ON LOWER RIGHT HALF OF ECHO BED WHEN DISMOUNTING. POLE HOLDERS HAVE BEEN REMOVED FROM BOTH OF THE ECHO BEDS. ONE BED HAS BEEN QUARANTINED BY THE DEPARTMENT; THE OTHER IS BEING HELD BY QUALITY AND SAFETY. THE ECHOBED THAT WAS USED IS WORKING PROPERLY. WE HAVE BEEN USING TWO ECHOBEDS IN OUR DEPARTMENT FOR SEVERAL YEARS WITHOUT INCIDENT. THE TOP AND SIDES OF THE ECHOBED ARE IN GOOD SHAPE.THERE ARE NO SHARP EDGES ON THE LOWER 1/2 OF THE ECHOBED.THE ECHOBEDS HAVE NOT BEEN MODIFIED SINCE PURCHASE. THE PATIENT DID REQUIRE A PROCEDURE AS A RESULT OF THE INJURY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ECHOCARDIOGRAM.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.