FDA.reportPublic FDA data

MAUDE MDR 7701522

MDR report key
7701522
Report number
3007602316-2018-00003
Event key
0
Event type
3
Date of event
2018-06-16
Date received
2018-07-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Contact
MR. DAVE PAUL
Address
1345 EASY LN EL DORADO HILLS 95762 US
Phone
877-877-8778
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1INDEPENDENCE STANDARD SETINDEPENDENCE STANDARD SETDAO HEALTHHGXFG066UPC 73066949664608.03.18.-02Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-1801. O

Event Narratives#

N

Patient 1

ON 07-09-2018 - PUMP WAS RECEIVED FROM CUSTOMER AND IS BEING INSPECTED TO DETERMINE CAUSE. ON 07/10/2018 - INVESTIGATION COMPLETED. THE RETURNED PUMP APPEARED TO BE UN-OPENED AND LOOKED NORMAL. NO VISUAL OBSERVATIONS NOTICED UPON INITIAL VISUAL INSPECTION AFTER OPENING THE PUMP. THE PUMP WAS TURNED ON AND IT WAS NOTICED THAT THE MOTOR WAS NOT CYCLING ON AND OFF AS IT SHOULD NORMALLY WITH EACH SUCTION AND RELEASE CYCLE, IT WAS CONTINUOUSLY RUNNING. THE MOTOR ALSO SEEMED TO RUN SLOW AND WITH A LOUDER THAN NORMAL SOUND. THE MOTOR WAS UNPLUGGED AND PLUGGED INTO ANOTHER PUMP CONTROL BOARD TO TEST THE OPERATION. THE MOTOR DISPLAYED THE SAME BEHAVIOR AND THE Q5 TRANSISTOR CHIP BEGAN TO SMOKE ALMOST IMMEDIATELY. NO FLAMES WERE VISIBLE. THE MOTOR WAS THEN PUT BACK INTO THE ORIGINAL PUMP AND TURNED ON. THE Q5 CHIP BEGAN TO SMOKE ALMOST IMMEDIATELY AND THE PUMP TURNED OFF. THERE WERE NO VISIBLE FLAMES. THE PUMP WAS TURNED BACK ON A FEW TIMES BUT WOULD ONLY RUN A SHORT AMOUNT OF TIME BEFORE SHUTTING OFF UNTIL THE MOTOR CEASED TO OPERATE. WHEN TURNED ON AGAIN THE PUMP STAYED ON AS IT NORMALLY WOULD AND THE SOLENOID CONTINUES TO WORK BUT THE MOTOR DOES NOT. THE BOARD WAS THEN INSPECTED UNDER THE MICROSCOPE, SEE ATTACHED IMAGES THE FRIED Q5 CHIP. BASED ON THE ABOVE INVESTIGATION, THERE SEEMS TO BE SOME TYPE OF MALFUNCTION OF THE MOTOR. THE MOTOR IS BEING SENT BACK TO THE MOTOR SUPPLIER (SHENZHEN DEYUXIN TECHNOLOGY CO.,LIMITED) FOR FURTHER INVESTIGATION. THERE WERE NO VISIBLE FLAMES FROM THE CHIP ON THE CONTROL BOARD, HOWEVER, THE CHIP DID SMOKE AND THE CONTROL BOARD/PUMP WAS NO LONGER OPERATIONAL. THIS IS THE SECOND PUMP UNIT TO DISPLAY THIS BEHAVIOR, REFERENCE MDR - (B)(4) FOR THE OTHER INVESTIGATION. [(B)(4)].

D

Patient 1

THE CUSTOMER REPORTED THAT AFTER TWO WEEKS OF USE WHILE IN THE MIDDLE OF A PUMP SESSION, THE PUMP STARTED VIBRATING CONSTANTLY, AND RAPIDLY, ALL THE LIGHTS FLASHING, INSTANT BATTERY LIFE LOSS, AND THEN WHEN SHE SHUT IT OFF, A PUFF OF SMOKE CAME FROM THE CHARGE PORT, AND IT CONTINUED TO VIBRATE ON ITS ON FOR ALMOST 20 MINUTES, ALL WHILE THE PUMP SEEMED TO GET WARMER.