SCALACOMBI

Additional Manufacturer Narrative

THIS EVENT OCCURED IN GERMANY. ALBER IS FILING THIS REPORT BECAUSE THE DEVICE IS MARKETED AND SOLD IN THE U.S. DURING THE INVESTIGATION OF THE AFFECTED DEVICE, WE WERE UNABLE TO REPRODUCE THE SCALACOMBI TIPPING OVER TO THE RIGHT BY A PERSON WEIGHING 50 KG WITH THE ARMRESTS ON/ATTACHED. WHETHER THE (REMOVABLE) ARMRESTS WERE IN PLACE AT THE TIME OF THE INCIDENT IS BEYOND OUR KNOWLEDGE. HOWEVER, IF THE ARMRESTS HAD NOT BEEN FITTED, THE PERSON WOULD HAVE FALLEN OUT OF THE SEAT UNIT WITHOUT THE SCALACOMBI TIPPING OVER. THEREFORE, WE CAN ONLY ASSUME THE TIPPING OVER OF THE SCALACOMBI, MAY HAVE BEEN CAUSED DUE UNKNOWN EXTERNAL FACTORS. THE SCALACOMBI WAS DEVELOPED IN ACCORDANCE WITH THE APPLICABLE ISO 7176-28 STANDARD AND ADDITIONALLY, WE HAVE A TÜV SÜD CERTIFICATE FOR THIS PRODUCT (ON A VOLUNTARY BASIS), WHICH INCLUDES AN ANNUAL PRODUCTION INSPECTION. IN ADDITION, OUR POST MARKET SURVEILLANCE (PMS) SYSTEM WOULD HAVE FLAGGED UP ANOMALIES IF THERE WERE A DESIGN OR USABILITY PROBLEM, BUT THERE IS NOT A SINGLE OTHER KNOWN CASE OF THIS KIND. ON PAGE 2, CHAPTER 1.3 INTENDED USE, THE INSTRUCTION MANUAL STATES: "THE PERSON BEING TRANSPORTED MUST BE ABLE TO SIT INDEPENDENTLY." IF THE PERSON FALLS ASLEEP, AS THE NEPHEW ASSUMES, THIS DOES NOT FALL UNDER THE INTENDED USE. THERE IS NO INDICATION OF MALFUNCTION OR PATIENT INJURY AT THE TIME OF THE INCIDENT. THEREFORE, WE DO NOT CONSIDER A CAUSAL LINK BETWEEN THE PATIENT'S DEATH AND OUR SCALACOMBI STAIRCLIMBER. NEVERTHELESS, WE ARE REPORTING THIS INCIDENT DUE TO THE SUBSEQUENT INFORMATION ABOUT THE PATIENT'S DEATH.

Description of Event or Problem

NARRATIVE TRANSLATION: THE STAIR CLIMBER WAS STANDING ON THE VERY HARD AND FIRMLY TWISTED CARPET, WHICH IN ITSELF ONLY GIVES WAY VERY LITTLE. AS WE HAD PLANNED TO GO FOR A WALK WITH MY AUNT (IN A WHEELCHAIR), OUR TWO CARERS DRESSED MY AUNT AND THEN PREPARED HER IN THE BEDROOM ON THE SCALAMOBIL SO THAT I COULD TAKE HER DOWN THE STAIRS. SHE SAT THERE FOR A FEW MINUTES IN THE PRESENCE OF ONE OF OUR TWO CARERS, WHO SAT OPPOSITE HER IN THE CHAIR. SUDDENLY, THE CHAIR TILTED TO THE RIGHT FOR NO APPARENT REASON. THE HANDLES SCRAPED ACROSS THE CUPBOARD BEHIND IT AND LEFT A SCRATCH. I ASSUME THAT MY AUNT HAD FALLEN ASLEEP (WHICH HAPPENS VERY OFTEN AND QUICKLY) AND HAD SLIPPED TO THE RIGHT EDGE OF THE CHAIR. OF COURSE, IT'S IMPOSSIBLE TO RECONSTRUCT THIS EXACTLY AFTERWARDS. FORTUNATELY, MY AUNT HAD NO PAIN OR RECOGNISABLE INJURIES. THE DOCTOR WHO EXAMINED HER AFTERWARDS ALSO FOUND NO INJURIES. INFORMATION FROM THE NEPHEW AFTER THE EXAMINATION AND OFFER PREPARATION: MY DEAR AUNT, (B)(6), UNFORTUNATELY PASSED AWAY LAST WEEK - POSSIBLY ALSO DUE TO A LATE CONSEQUENCE OF THE FALL. AS WE WERE AWARE, THE STAIR CLIMBER TIPPING OVER WAS NOT A MALFUNCTION OF THE DEVICE, BUT DUE TO THE LACK OF LATERAL GUIDANCE OF THE PATIENT, IT WAS ALSO AN EVENT TRIGGERED BY THE DEVICE. IT WAS ONLY BECAUSE OF THIS LACK OF GUIDANCE THAT THE GAUNT, IMMOBILE PATIENT WAS ABLE TO CAUSE THE HEAVY CHAIR TO TIP OVER BY SLUMPING AND SLIPPING HER UPPER BODY. IT SHOULD BE NOTED THAT EVEN THE LAP BELT, WHICH I WAS ADVISED NOT TO ORDER AT THE TIME DESPITE ASKING YOU, WOULD NOT HAVE PREVENTED THE CHAIR FROM TIPPING OVER. ULTIMATELY, THE APPLIANCE TIPPED OVER DUE TO A LIFE-THREATENING FAULTY DESIGN; FORTUNATELY, THIS DID NOT CAUSE ANY DIRECT PERSONAL INJURY AND THE APPLIANCE ITSELF ONLY SUFFERED MINOR DAMAGE. HOWEVER, INSTEAD OF REPLACING THE BROKEN BRAKE ROLLER ON SITE, THE MANUFACTURER INSISTED ON TAKING THE APPLIANCE BACK TO THE FACTORY. I NOW CONSIDER THE REPAIR OFFER TO BE OUTRAGEOUS. I EXPECT THAT EITHER THE DAMAGE WILL BE REPAIRED FREE OF CHARGE AND THE APPLIANCE WILL BE RETURNED TO US OR, BETTER STILL, THAT THE MANUFACTURER OR YOU WILL MAKE US A REASONABLE OFFER TO TAKE THE APPLIANCE BACK, TAKING DUE ACCOUNT OF ITS USE OVER THE PAST FEW MONTHS.