N
Patient 1
SERIAL NUMBER: REQUESTED, BUT UNAVAILABLE.
MAUDE MDR 7939691
- MDR report key
- 7939691
- Report number
- 3012446970-2018-00007
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-09-24
- Date received
- 2018-10-05
- 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
- BRIAN BECKER
- Address
- 1430 DECISION STREET VISTA CA 92081 US
- Phone
- 760-760-7607
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-10-05 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THERE WAS A SHORTAGE IN THE COMPEX DEVICE THAT CAUSED IT TO CATCH FIRE AND SPREAD TO THE END USER'S KITCHEN TABLE. THE DEVICE WAS STORED IN THE BOX IT CAME IN WITH THE PADS AND INSTRUCTIONAL PAPER ON TOP OF THE END USER'S KITCHEN TABLE. THE DEVICE WAS CHARGED BEFOREHAND, BUT IT WAS DISCONNECTED WHILE IN THE BOX. NOTHING WAS BURNED BESIDES THE KITCHEN TABLE, BUT A LOT OF SMOKE SPREAD THROUGHOUT THE HOUSE. NO ONE WAS AT THE HOUSE DURING THE ACCIDENT EXCEPT FOR THE END USER'S DOG, WHOM A VETERINARIAN CONFIRMED WAS UNHARMED. FIREFIGHTERS WERE CALLED TO THE SCENE TO EXTINGUISH THE FIRE. THE INVOLVED FIRE DEPARTMENT IS REPORTEDLY UNABLE TO RETURN THE DEVICE.
N
Patient 1
THE REPORT FROM THE RESPONDING FIRE DEPARTMENT STATES "IT APPEARED FIRE STARTED FROM FAULTY ELECTRO MUSCLE STIMULATOR INSIDE A BOX WITH PAPERS." HOWEVER, THERE IS NO EVIDENCE THAT A TECHNICAL INVESTIGATION OF THE DEVICE WAS PERFORMED. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. THE END USER ORIGINALLY STATED THE FIRE DEPARTMENT TOOK THE DEVICE. HOWEVER, WHEN CONTACTING THE FIRE DEPARTMENT, DJO WAS INFORMED THAT THE DEVICE WAS NOT REMOVED FROM THE END USER'S HOME. THE END USER WAS THEN CONTACTED AND STATED THAT THE DEVICE WAS REMOVED BY THE CLEANING COMPANY AND SUBSEQUENTLY DISCARDED. A ROOT CAUSE OF THE FIRE CANNOT BE DETERMINED, NOR CAN IT BE CONCLUSIVELY TRACED TO THE COMPEX UNIT. THE RISK DOCUMENTATION AND SAFETY CERTIFICATIONS WERE REVIEWED AND FOUND TO BE ACCEPTABLE.