FDA Adverse Event Summary report: N

ECHOBED DUAL

MDR report key: 3232378 · Received July 16, 2013

Report

Report Number: 3232378
Date Received: July 16, 2013
Date of Event: July 5, 2013
Report Date: July 15, 2013
Manufacturer: MEDICAL POSITIONING, INC
Product Code: LGX
Report Source: User Facility report
Reporter Location: MD, US

Narratives

Description of Event or Problem · 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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
330153	ECHOBED DUAL	TABLE, EXAMINATION, MEDICAL, POWERED	LGX	MEDICAL POSITIONING, INC	1222	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR