FDA.reportPublic FDA data

MAUDE MDR 2493875

MDR report key
2493875
Report number
3004082462-2012-00001
Event key
0
Event type
3
Date of event
2012-01-05
Date received
2012-02-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
1441 WOLF CREEK TRAIL SHARON CENTER OH 44274 US
Phone
330-330-3302
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TRANSMOTION MEDICAL, INC.TMM4 SERIES MULTI-PURPOSE STRETCHER/CHAIGBBTMM4-XWTRFBTMM4-XWTRFB3990N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-02-030

Event Narratives#

N

Patient 1

A FULL WRITTEN REPORT WAS REQUESTED FROM THE FACILITY REGARDING THE INCIDENT ON TWO OCCASIONS (B)(6) 2012 AND WE HAVE YET TO RECEIVE. THEREFORE, THE DETAILS OF THE AGE/WEIGHT OF THE PATIENT ARE NOT EXACTLY KNOWN AS DIFFERENT ANSWERS WERE PROVIDED FROM DIFFERENT MEMBERS OF THE STAFF. AN INITIAL INSPECTION WAS CONDUCTED BY (B)(4) (TMM SALES REPRESENTATIVE) ON (B)(4) 2012, ALONG WITH (B)(4), AND NOTHING WAS FOUND TO BE WRONG WITH THE CHAIR. THE CHAIR WAS INSPECTED BY (B)(4) ON (B)(4) 2012, WHILE ON-SITE AT (B)(6) MEMORIAL. THE CHAIR WAS FULLY FUNCTIONAL AND NO ISSUE WAS FOUND WITH THE BACK ACTUATOR. THE ONLY POSSIBLY SCENARIO IS THAT THE PATIENT OR CAREGIVER ACCIDENTALLY PULLED THIS LEVER CAUSING THE BACK SECTION TO DROP AS DESIGNED. THE PATIENT WAS NOT WEARING THE SAFETY STRAP. AN INSPECTION LETTER WAS SENT TO (B)(4) VIA EMAIL ON (B)(4) 2012, STATING THE CHAIR WAS FULLY FUNCTIONAL.

D

Patient 1

THE PRODUCT WAS IN A RECLINE POSITION AND IT SUDDENLY WENT INTO TRENDELENBURG POSITION. THE PATIENT SLID DOWN THE SURFACE AND HIT HER HEAD AGAINST THE WALL.