MAUDE MDR 5637598

MDR report key
5637598
Report number
1417592-2016-00056
Event key
0
Event type
3
Date of event
2016-03-23
Date received
2016-05-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
DIANE CHRISTENSEN
Address
ONE MEDLINE PLACE MUNDELEIN IL 60060 US
Phone
847-847-8476
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TRANSPORT CHAIRMEDLINE INDUSTRIES, INC.INMMDS808200WXU140607371Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-05-0601. O

Event Narratives#

N

Patient 1

THE END USER'S DAUGHTER REPORTED THAT WHILE PUSHING ON THE HANDLES TO CLEAR A CURB, THE LEFT LATCH RELEASED AND THE END USER FELL OUT OF THE TRANSPORT CHAIR ON TO THE GROUND. HER DOCTOR DIAGNOSED A RIB FRACTURE BUT IT IS UNKNOWN IF ANY X-RAYS WERE DONE TO CONFIRM THAT DIAGNOSIS. THE END USER'S DAUGHTER STATED THAT SHE HAD TIGHTENED THE RELEASE PIN FOR THE LEFT PUSH HANDLE PRIOR TO THIS INCIDENT. THE SAMPLE HAS BEEN RETURNED FOR EVALUATION. IT WAS CONFIRMED THAT AN ADJUSTMENT WAS MADE TO THE RELEASE PIN FOR THE LEFT PUSH HANDLE. THE RELEASE PIN WAS NOT PROTRUDING ENOUGH TO LOCK THE HANDLE INTO PLACE. WHEN ADJUSTED CORRECTLY, THE LEFT HANDLE SECURELY LOCKED INTO PLACE. IT IS UNKNOWN IF THE SEAT BELT WAS APPLIED AS RECOMMENDED IN THE OWNER'S MANUAL. THE OWNER'S MANUAL ALSO STATES NOT TO ATTEMPT TO RIDE OVER CURBS OR OBSTACLES. DOING SO MAY CAUSE YOUR CHAIR TO TIP OVER. THE OWNER'S MANUAL FURTHER STATES TO MAKE SURE THAT THE SEATBACK IS LOCKED IN THE UPRIGHT POSITION. WE HAVE DETERMINED THAT THE MOST LIKELY ROOT CAUSE FOR THIS INCIDENT TO BE USER ERROR.

D

Patient 1

THE END USER'S DAUGHTER REPORTED THAT WHILE PUSHING ON THE HANDLES TO CLEAR A CURB, THE LEFT LATCH RELEASED AND THE END USER FELL OUT OF THE TRANSPORT CHAIR ON TO THE GROUND AND SUFFERED A RIB FRACTURE.