FDA Adverse Event Malfunction Summary report: N

ORTHOFIX ACCELSTIM

MDR report key: 20127523 · Received August 30, 2024

Report

Report Number
MW5159168
Event Type
Malfunction
Date Received
August 30, 2024
Date of Event
August 24, 2024
Report Date
August 28, 2024
Manufacturer
ORTHOFIX US LLC
Product Code
LOF
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I HAVE AN ORTHOFIX BONE STIMULATOR. THE DEVICE IS SUPPOSED TO BE USED TWICE DAILY FOR 20 MINUTES EACH TIME (40 MINUTES TOTAL). THE "DAY" RESETS AT MIDNIGHT CDT, NO MATTER WHERE YOU ARE, AND THE TIME ZONE CANNOT BE RESET. THE DEVICE ALSO CANNOT BE USED AND CHARGED AT THE SAME TIME. IF THE BATTERY GETS LOW DURING A CYCLE, THE DEVICE WILL BEEP AND SHUT OFF. ONCE IT IS THEN SUBSEQUENTLY CHARGED, IT WILL RESUME THE CYCLE WHERE IT LEFT OFF WHEN YOU TURN IT BACK ON. SO, FOR EXAMPLE, IF YOU RUN IT FOR 12 MIN, THEN THE BATTERY DIES, THEN YOU CHARGE IT, WHEN YOU RESUME IT WILL COMPLETE THE EIGHT (8) MINUTES REMAINING. THE DEVICE IS DESIGNED SO THAT ONCE IT IS USED FOR 40 MINUTES DAILY, IT WILL STOP FUNCTIONING UNTIL THE FOLLOWING DAY. ON SATURDAY, AUG 24TH, I USED THE DEVICE FOR 20 MIN AT APPROXIMATELY 3 AM CDT. I WAS IN (B)(6), SO IT WAS ACTUALLY APPROXIMATELY 10 PM ON FRIDAY THE 23RD IN (B)(6), BUT THE DEVICE CANNOT BE REPROGRAMMED FOR DIFFERENT TIME ZONES. AROUND 5 PM CDT ON THE 24TH (NOON IN (B)(6)), I USED THE DEVICE FOR A SECOND TIME, BUT THE BATTERY DIED AFTER SEVEN MINUTES. I CAUGHT A FLIGHT TO (B)(6) AND RE-CHARGED THE DEVICE. AROUND 11:55PM CDT (9:55PM PDT), I RAN THE REMAINING 13 MINUTES OF MY SESSION. AT THIS TIME, THE DEVICE MALFUNCTIONED. IT REPORTED THAT I HAD SUCCESSFULLY USED THE DEVICE TWICE ON THE SUNDAY, THE 25TH OF AUGUST, BUT NOT AT ALL ON SATURDAY, THE 24TH OF AUGUST. BECAUSE OF THIS MALFUNCTION, I WAS NOT ABLE TO USE THE DEVICE ON SUNDAY THE 25TH BECAUSE I WAS LOCKED OUT. THE DEVICE "RESET" ON THE 26TH AND HAS BEEN FUNCTIONING NORMALLY SINCE THEN. I CALLED THE MANUFACTURER TO REGISTER A COMPLAINT, BUT THEY IGNORED MY COMPLAINT. THEY SAID THE DAY RESETS AT 10 PM CENTRAL TIME, AND THAT MY DEVICE IS FUNCTIONING NORMALLY. THIS IS INCORRECT; THE DEVICE MALFUNCTIONED. INSTEAD OF REGISTERING MY COMPLAINT THEY "NOTATED MY ACCOUNT," WHICH IS UNSATISFACTORY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1056227 ORTHOFIX ACCELSTIM STIMULATOR, BONE GROWTH, NON-INVASIVE LOF ORTHOFIX US LLC

Patients

Seq Age Sex Outcome Treatment
1 Female