FDA.reportPublic FDA data

MAUDE MDR 9889168

MDR report key
9889168
Report number
3009897021-2020-00122
Event key
0
Event type
3
Date of event
2020-02-26
Date received
2020-03-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. STEVEN JACKSON
Address
6203 FARINON DRIVE SAN ANTONIO, TX US
Phone
255-255-2556
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ACTIV.A.C.? THERAPY SYSTEMOMPKINETIC CONCEPTS, INC.OMPWNDACTY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-270

Event Narratives#

N

Patient 1

BASED ON THE INFORMATION OBTAINED REGARDING THE DEVICE, KCI FOUND EVIDENCE THAT THE DEVICE HAD A COLLAPSED DOME. THERE IS NO INJURY ASSOCIATED WITH THIS EVENT. KCI IS REPORTING THIS EVENT FOUND DURING SERVICING OF THE UNIT AS A DEVICE MALFUNCTION THAT HAS THE POTENTIAL TO RESULT IN INJURY IF IT WERE TO RECUR.

D

Patient 1

ON (B)(6) 2020, KCI TECHNICAL SERVICES IDENTIFIED A POWER SWITCH WITH COLLAPSED DOME. ON 2(B)(6) 2020, KCI QUALITY ENGINEERING PERFORMED AN EVALUATION OF THE DEVICE. INSPECTION OF THE DEVICE FOUND THE POWER BUTTON WAS COLLAPSED.