FDA.reportPublic FDA data

MAUDE MDR 3253582

MDR report key
3253582
Report number
3007873415-2013-00002
Event key
0
Event type
3
Date of event
2012-01-26
Date received
2013-06-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
LYLE SHERWOOD
Address
333 ELM STREET DEDHAM MA 02026 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TOBIIC-12TOBII ELECTRONICS TECHNOLOGY SUZHOU CO., LTD.ILQC-12Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-06-030

Event Narratives#

D

Patient 1

WHEELCHAIR POWER ADAPTER SHORTED OUT AND MELTED. FUSE BLEW BUT THERE STILL APPEARED TO BE ADDITIONAL DAMAGE TO WIRE. I ASKED (B)(6) TO CALL IN TO TECH SUPPORT ABOUT IT AND TO SEND US PHOTOS AND/OR THE ITEM FOR ANALYSIS. C12 DOES NOT APPEAR TO BE DAMAGED, NO INJURIES, JUST CONCERN ABOUT SAFETY OF THIS ITEM.

N

Patient 1

A UNIT WAS REPORTED FAULTY IN THE FIELD AND RETURNED TO US - UPON CLOSER INSPECTION, IT SEEMS AS IF A SHORT CIRCUIT OCCURRED. THE REASON IS LIKELY DUE TO IMPROPER THIRD PARTY INSTALLATION, RESULTING IN A GROUNDING FAULT BETWEEN THE WHEELCHAIR CHASSIS AND THE WHEELCHAIR BATTERY. UNDER THIS CIRCUMSTANCE, AND IN THE CASE OF A SHORT CIRCUIT, THERE IS A RISK OF A HEAT RUSH WHICH COULD CAUSE A FIRE. WE FEEL THAT THE CONSEQUENCES COULD HAVE BEEN SIGNIFICANT ENOUGH THAT WE HAVE MADE THE DECISION TO IMPLEMENT ADDITIONAL SAFETY MEASURES TO THE DESIGN, AND RETROACTIVELY FIT ALL UNITS IN THE FIELD AT NO CHARGE TO THE CUSTOMER.