FDA.reportPublic FDA data

MAUDE MDR 5202090

MDR report key
5202090
Report number
1319061-2015-00001
Event key
0
Event type
3
Date of event
2015-10-15
Date received
2015-11-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
111
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
TRAVIS SCOTT
Address
2032 RT 213 PO BOX 903 RIFTON NY 12471 US
Phone
845-845-8456
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SMALL DYNAMIC STANDERMOBILE STANDERRIFTON EQUIPMENTIPLK130K130Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-11-040

Event Narratives#

N

Patient 1

VISUAL ANALYSIS OF THE FAILED COMPONENT SUGGESTS THAT THERE WOULD LIKELY HAVE BEEN VISIBLE CRACKING OF THE PART WELL BEFORE THE FAILURE THAT RESULTED IN THIS INCIDENT. SUCH CRACKING WOULD BE OBVIOUS TO A USER COMPLYING WITH THE INSTRUCTIONS IN THE DEVICE MANUAL TO PERIODICALLY INSPECT THE DEVICE FOR CRACKS. THE PRODUCT MANUAL INSTRUCTIONS SAY: "TO PREVENT STRUCTURAL FAILURE, WHICH MAY RESULT IN SERIOUS INJURY OR DEATH: INSPECT THIS PRODUCT AND ACCESSORIES REGULARLY FOR LOOSE OR MISSING SCREWS, METAL FATIGUE, CRACKS, BROKEN WELDS, MISSING ATTACHMENTS, GENERAL INSTABILITY OR OTHER SIGNS OF EXCESSIVE WEAR. IMMEDIATELY REMOVE THIS PRODUCT FROM USE WHEN ANY CONDITION DEVELOPS THAT MIGHT MAKE OPERATION UNSAFE."

D

Patient 1

IT WAS REPORTED THAT AS STAFF WAS PUTTING THE STUDENT INTO THE MOBILE STANDER, A STRUCTURAL COMPONENT OF THE STANDER FAILED, ALLOWING THE BODY SUPPORT TO SEPARATE FROM THE FRAME OF THE STANDER.