FDA.reportPublic FDA data

MAUDE MDR 7771090

MDR report key
7771090
Report number
1419185-2018-00004
Event key
0
Event type
3
Date received
2018-08-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. JESSICA BARRILE
Address
1111 LAKESIDE DR GURNEE IL 60031 US
Phone
847-847-8478
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CARE-E-VAC 3PORTABLE SUCTION DEVICEOHIO MEDICAL LLCBTA758000758000CEB181003Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-090

Event Narratives#

N

Patient 1

FIELD CORRECTION 1419185-7/24/18-001-C HAS BEEN INITIATED FOR CORRECTION OF OTHER POTENTIALLY AFFTECTED DEVICES.

D

Patient 1

ON (B)(6) 2018 A COMPLAINT WAS RECEIVED FOR THE CARE-E-VAC 3 DEVICE IN WHICH THE CUSTOMER STATED "UNIT WAS SMOKING AND HAD TO CLEAR OUT THE UNIT FROM ROOM LOCATED, HE FOUND BURNT WIRES AND BURNT MARKS INSIDE THE UNIT". CUSTOMER WAS CONTACTED ON 4/11/2018 TO OBTAIN ADDITIONAL INFORMATION. IT WAS STATED BY MR. (B)(6) THAT HE RECEIVED A CALL ABOUT SMOKE DETECTED ON A PATIENT FLOOR. THE AREA WAS EVACUATED BECAUSE IT COULD NOT BE DETERMINED WHERE THE SMOKE WAS COMING FROM. MR. (B)(6) REMOVED 3 DIFFERENT PORTABLE DEVICES AND BROUGHT THEM TO THE BIO-MED AREA FOR FURTHER INVESTIGATION, AND AREA WAS THEN ALLOWED TO BE USED. WHILE IN THE BIOMED AREA THE CARE-E-VAC 3 DEVICE WAS OPENED UP AND IT WAS THEN NOTED THAT INSULATION ON WIRES HAD MELTED. IT WAS STATED BY MR. (B)(6) THAT THE DEVICE WAS BEING STORED (NOT IN USE) ON THE DEPARTMENT CODE CART WHEN SMOKE SMELL WAS NOTED, AND THAT THE LAST TIME THE DEVICE WAS VERIFIED TO BE IN WORKING ORDER WAS SOMETIME DURING FEBRUARY 2018. UPON RETURN TO THE MANUFACTURER ON 04/23/2018 THE FOLLOWING WAS NOTED BY THE REPAIR TECHNICIAN "DUE TO EXTENT OF DAMAGE, UNIT IS BEYOND ECONOMICAL REPAIR (BER)." A REPLACEMENT DEVICE WAS SENT TO THE CUSTOMER. IT WAS DETERMINED BY ENGINEERING THAT THE DEVICE MAY HAVE BEEN CONTAMINATED DURING STORAGE ON THE CODE CART AND NO FURTHER ACTIONS WERE NECESSARY. DEVICE WAS RETAINED BY ENGINEERING. ON 6/22/2018 THERE WAS AN OCCURENCE IN HOUSE DURING ASSEMBLY OF THE CARE-E-VAC 3 DEVICE IN WHICH SAME TIME OF EFFECT OCCURED (MELTED WIRES LEADING FROM BATTERY TO THE PC BOARD). SHIP HOLD WAS INITIATED IMMEDIATELY AND INVESTIGATION BEGAN LOOKING FURTHER INTO THE CAUSE OF THE MELTED WIRES.