MTD4000

Description of Event or Problem

PHYSICIAN USED DEVICE TO TREAT A PT WITH NECK PROTOCOL AT (B)(6). FORCE, REST 15 SECONDS, (B)(6) HOLD FOR 30 SECONDS FOR TOTAL TREATMENT TIME OF 10 MINUTES. THE DEVICE OVER-PULLED AND ALLEGEDLY CAUSED NECK INJURY. PRESSING NURSE CALL BUTTON AND STOP BUTTON ALLEGEDLY DID NOT WORK. DEVICE WAS TURNED OFF BY TURNING OFF THE MAIN POWER SWITCH. (B)(4) RECEIVED AN EMAIL NOTICE FROM (B)(6) THAT WAS A FORWARDED LETTER FROM DR. (B)(6) OF (B)(6) IN (B)(6). IN THE EMAIL, DR. (B)(6) WROTE THAT HER FEMALE PATIENT WAS ON THE TABLE FOR DECOMPRESSION OF HER NECK WHEN THE TRACTION HEAD PULLED AND PULLED - NOT EVENT STOPPING WHEN THEY PRESSED STOP. THE MACHINE ONLY STOPPED WHEN THEY TURNED THE MACHINE OFF WITH THE BACK POWER SWITCH. LATER I WAS INFORMED FROM (B)(4) THAT THE PT KILL SWITCH AND STOP BUTTON DID NOT WORK. HE ALSO TOLD ME THAT THE DEVICE WAS PULLING AT APPROX (B)(6).

Additional Manufacturer Narrative

WHEN (B)(4) RECEIVED THE DEVICE, WE OPENED IT AND NOTICED THAT THE CABLE HAD SLIPPED OFF THE PULLEY AND THAT THERE WERE PIECES OF PLASTIC, TORN OFF THE CABLE, INSIDE THE UNIT. AFTER TAKING PICTURES AND SENDING THEM TO (B)(4), (B)(4) CLOSED THE UNIT AND RETURNED THE UNIT TO (B)(4), FOR THEM TO EVALUATE. THE UNIT WAS RETURNED TO (B)(4) ON (B)(4) 2011 AND IS CURRENTLY IN (B)(4).