FDA.reportPublic FDA data

MAUDE MDR 9886849

MDR report key
9886849
Report number
3009897021-2020-00125
Event key
0
Event type
3
Date of event
2020-02-13
Date received
2020-03-26
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
12020-03-260

Event Narratives#

N

Patient 1

BASED ON THE INFORMATION OBTAINED REGARDING THE DEVICE, KCI FOUND EVIDENCE THAT THE DEVICE HAD A COLLAPSED POWER SWITCH. THERE IS NO INJURY ASSOCIATED WITH THIS EVENT. KCI IS REPORTING THIS EVENT AS A DEVICE MALFUNCTION THAT HAS THE POTENTIAL TO RESULT IN INJURY IF IT WERE TO RECUR. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: WARNINGS KEEP V.A.C.? THERAPY ON: NEVER LEAVE A V.A.C.? DRESSING IN PLACE WITHOUT ACTIVE V.A.C.? THERAPY FOR MORE THAN TWO HOURS. IF THERAPY IS OFF FOR MORE THAN TWO HOURS, REMOVE THE OLD DRESSING AND IRRIGATE THE WOUND. EITHER APPLY A NEW V.A.C.? DRESSING FROM AN UNOPENED STERILE PACKAGE AND RESTART V.A.C.? THERAPY, OR APPLY AN ALTERNATE DRESSING AT THE DIRECTION OF THE TREATING PHYSICIAN.

D

Patient 1

ON 13-FEB-2020, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THE ACTIV.A.C.? THERAPY SYSTEM SHUTS OFF ON ITS OWN. ON (B)(6) 2019, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI SERVICE CENTER, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS PRIOR TO PATIENT PLACEMENT. ON (B)(6) 2019, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2020, KCI QUALITY ENGINEERING PERFORMED AN EVALUATION OF THE DEVICE FOUND THE POWER BUTTON WAS COLLAPSED.