inforMED
InjuryBZK

SYSTEM ONE RESPIRATOR

Received Feb 27, 2018 · Event occurred Oct 1, 2017

Report MW5075570 · MDR key 7302441

Device

Generic name

System One Respirator

Model number

SYSTEM ONE

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

82 YR

  • Fall
  • Dizziness
  • Fall
  • Dizziness

Narrative

Description of Event or Problem

FELL TWICE, JUST DROPPED WITHOUT ANY INDICATIONS. HAVING DIZZY SPELLS. FEELING PRESSURE BETWEEN MY EARS (HEAD) WENT TO DR, SAID HAD DEFECT IN MY LEFT INNER EAR. PRESCRIBED PHYSICAL THERAPY, FOUR SESSIONS, NO HELP. FELT BETTER FOR A WHILE. POSSIBLE SIDE EFFECTS FROM COMBINATION OF BREATHING MACHINE, AMLODIPINE BESYLATE 5 MG, LOSARTAN 100-25MG AUR, METFORMIN HCL DR 500 MG TABS, INSULIN HUMALOG AND BASAGLAR. AN (B)(6) MALE. DATES OF USE: 2 YEARS. DIAGNOSIS OR REASON FOR USE: SLEEP. "EVENT ABATED AFTER USE STOPPED: NO."