BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REDMAN POWER CHAIR

    MDR report key: 507450 · Received January 12, 2004

    Report

    Report Number
    MW1030788
    Event Type
    Injury
    Date Received
    January 12, 2004
    Date of Event
    February 21, 2000
    Report Date
    December 29, 2003
    Manufacturer
    PACIFIC WESTERN DEVICES & REDMAN POWER CHAIRS, LLC
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 03/15/04: REDMAN POWER CHAIR'S FILES SHOW THAT THE LEGAL DISPUTE BETWEEN THE CUSTOMER AND THE COMPANY WAS CONCLUDED IN NOVERBER 2003 WHEN THE CUSTOMER'S ATTORNEY ACCEPTED (ON THE CUSTOMER'S BEHALF) A CASH SETTLEMENT FROM THE COMPANY. ON THE ADVISE OF LEGAL COUNSEL, REDMAN POWER CHAIR, LLC WAS DISSOLVED IN MARCH 2004 AND THAT DISSOLUTION IS BEING CONDUCTED UNDER STATE OF ARIZONA LAWS GOVERNING SUCH ACTIVITIES. PACIFIC WESTERN DEVICES EXPECTS TO APPOINT A NEW DOMESTIC DISTRIBUTOR WITHIN 30 DAYS. THE CO'S FILES SHOW THAT THIS CUSTOMER IS ACTIVE (MEANING THEY ARE STILL USING THE POWERED WHEELCHAIR THEY PURCHASED FROM REDMAN POWER CHAIR) AND THAT CHAIR IS NO LONGER COVERED UNDER THE LIMITED WARRANTY ISSUED WITH CHAIR WHEN PURCHASED. ALTHOUGH REDMAN POWER CHAIR HAS BEEN DISSOLVED, THE CO'S CUSTOMER AND TECHNICAL SERVICE DEPTS REMAIN AVAILABLE TO ALL OF REDMAN POWER CHAIR'S CUSTOMERS INCLUDING THE CUSTOMER REFERENCED IN THIS LETTER.

    Description of Event or Problem · 1

    THE PROBLEMS OR EVENTS CONCERN PT'S PURCHASE OF A REDMAN CHIEF 107SR POWER WHEELCHAIR WHICH WAS DELIVERED IN 2000. AT FIRST PT THOUGHT THERE WERE JUST A FEW PROBLEMS WHICH NEEDED TO BE ADJUSTED, BUT PT SOON LEARNED THERE WERE MANY, INCLUDING THE FALSE ADVERTISING AND FALSE PROMISES MADE TO THEM, TO ENTICE THEM TO PURCHASE THE WHEELCHAIR. PT EVENTUALLY LEARNED THEY HAD NO INTENTION OF HONORING THE "FULL 3 YEAR NO HASSLE GUARANTEE". THIS WHEELCHAIR COSTS ABOUT $25,000 BUT PT PAID ABOUT $19,500 PLUS AN EXTRA $1,000 FOR THE EZ LOCK TIE DOWN SYSTEM WHICH IS REQUIRED BY LAW. PT RECEIVED A DISCOUNT FOR PAYING BY CASH IN ADVANCE. SOME OF THE PROBLEMS PT ENCOUNTERED ARE VERY LOW GROUND CLEARANCE OF ABOUT 1/2 INCH INSTEAD OF THE ADVERTISED 4 INCHES. THIS CAUSES THEM TO GET HUNG UP ON THINGS OR TO "BOTTOM OUT" AND NOT GET TRACTION ON CERTAIN GRADES. THE WHEELCHAIR WAS NOT POWERFUL ENOUGH TO GET OVER A 3 INCH CURB, AND COULD BARELY MAKE A 1 1/2 INCH CURB. THE BRAKES WERE NOT WORKING. THE HAND CONTROLLER DID NOT WORK PROPERLY CAUSING THEM TO JERK TO THE SIDES WHEN TRYING TO TURN OR MANIPULATE THEIR POSITION. THE MOTORS PULL UNEQUALLY, ALSO CAUSING THE CHAIR TO VEER TO ONE SIDE, ESPECIALLY WHEN UNDER STRESS SUCH AS GOING OVER A DOOR SILL OR BACKING IN THE VAN OFF OF THE PLATFORM. THE CUSTOM BUILT, SMALL FOOTPLATES SCRAPED ON THE FRONT TIRES CAUSING DAMAGE. THE BEARINGS IN THE FRONT ASSEMBLIES WORE OUT VERY QUICKLY AND WOULD CAUSE FURTHER JERKING OF THE CHAIR. THIS CAUSED DAMAGE TO THE SIDE PANELS AND HEADLIGHTS. RUST BEGAN TO FORM ON THE FRAME AND REAR WHEEL AXLES ALMOST IMMEDIATELY. THEY HAVE SINCE CHANGED THE INSTRUCTION MANUAL TO STATE THAT THE WHEELCHAIR IS NOT TO BE USED IN RAIN OR HUMID ENVIRONMENTS, OR TO BE LEFT IN THE BATHROOM WHILE SHOWERING. THESE ARE IMPOSSIBLE RESTRICTIONS, ESPECIALLY FOR ONE WHO LIVES ALONE. THE WHEELCHAIR WAS SOLD TO THEM AS AN ALL-WEATHER, INDOOR-OUTDOOR POWER CHAIR. THE BATTERIES AND REAR TIRES HAVE HAD TO BE REPLACED THREE OR FOUR TIMES WITHIN THREE YEARS. THE TIRES AND BATTERIES LASTED AT LEAST FIVE YEARS ON PT'S TWENTY YEAR OLD INVACARE POWER CHAIR. THE BUILT IN BATTERY CHARGER ALSO MALFUNCTIONED CAUSING THE INTERCOM SYSTEM IN PT'S HOME TO MALFUNCTION DURING THE NIGHT. REDMAN DID NOT TRY TO FIX THE BATTERY CHARGER; THEY JUST SENT PT A USED, STAND-ALONE CHARGER WITH A BROKEN CONNECTOR FOR WHICH THEY CHARGED THEM $95.00. THERE IS SOME SORT OF ELECTRICAL LEAK WHICH CAUSES RADIO INTERFERENCE, MUCH MORE SO WHEN THE CHAIR IS TURNED OFF. REDMAN HAS MADE NO ATTEMPT TO DETERMINE THE CAUSE OR CORRECTION OF THIS PROBLEM. PT IS VERY WORRIED THAT THIS MIGHT CAUSE A PROBLEM WITH SOMEONE'S PACEMAKER, OR PRODUCE A SPARK WHICH WOULD IGNITE THE GAS GIVEN OFF BY THE BATTERIES. AT THE VERY LEAST, IT MAKES LISTENING TO A PORTABLE RADIO IMPOSSIBLE. THE FIRST NIGHT PT HAD THE WHEELCHAIR, IT STRANDED THEM IN THE STAND UP MODE, AND BY THE TIME SOMEONE COULD COME TO THE HOUSE AND RESCUE PT, THEY WERE HANGING BY THE SHOULDER STRAPS IN MUCH PAIN. THIS HAPPENED AGAIN WHILE IN A GROCERY STORE SOME DISTANCE FROM THEIR HOME. PT HAD TO GIVE UP USING THE STANDING FEATURE AS IT WAS SO UNRELIABLE. THE ACTUATOR, WHICH IS BOLTED UNDER THE SEAT, IS CRACKED. PT HAS BEEN WARNED NOT TO USE THE FUNCTIONS AS THEY WILL NOT WORK PROPERLY. EVENTUALLY, THE MOTORS GAVE OUT. PT WAS 2 1/2 HOURS AWAY FROM HOME WHEN THEIR WHEELCHAIR "DIED". REDMAN HAD FINALLY HIRED A MECHANIC BY THIS TIME, AND HE ESSENTIALLY REBUILT THE CHAIR, INCLUDING NEW MOTORS. THE PROBLEMS STILL REMAIN. THE RIGHT MOTOR ESPECIALLY HAS GIVEN OUT MORE THAN A FEWS TIMES. THE TIME BEFORE LAST, PT WAS WITHOUT THEIR WHEELCHAIR FOR ALMOST 2 WEEKS. IT TOOK 9 MONTHS FOR REDMAN TO GET BACK TO PT'S HOUSE TO TRY TO CORRECT THE MANY PROBLEMS. IT BECAME APPARENT THAT THE PROBLEMS COULD NOT BE CORRECTED AND PT DEMANDED THEIR MONEY BACK. OWNER AGREED TO GIVE PT THEIR MONEY BACK, BUT THEN THEY CALLED AND SAID THEY WERE IN THE PROCESS OF BUILDING A NEW MODEL WHEELCHAIR WHICH WOULD CORRECT ALL THE PROBLEMS INHERENT IN THE MODEL 107SR WHICH IS A STANDING, FULLY RECLINING POWER WHEELCHAIR WHICH ALSO ELEVATES THE LEGS. THEY PROMISED PT IN WRITING TO REPLACE THEIR CHAIR WITH THE NEW MODEL WITHIN 4 OR 5 MONTHS. THEY TOLD PT THEY WOULD HAVE TO BUY A NEW WARRANTY -SOMETHING PT LEARNED WAS ILLEGAL. PT WAS LATER TO LEARN THEY DECIDED A WEEK LATER TO NOT BUILD THE NEW MODEL. THEY KEPT LYING TO PT, WHILE AT THE SAME TIME PT COULD NOT GET THEM TO DO THE NECESSARY REPAIRS UNDER THE WARRANTY. THEY DID NOT CARE THAT PT WAS CONFINED AND THEIR LIFE DEPENDED ON A DANGEROUS, MALFUNCTIONING WHEELCHAIR. PT EVENTUALLY HIRED AN ATTORNEY TO REPRESENT THEM. TO MAKE A LONG STORY SHORT, REDMAN FILED FOR BANKRUPTCY TO ESCAPE ANY RESPONSIBILITY. PT LEARNED ON THEIR OWN THAT THIS IS THE FOURTH TIME THEY HAVE FILED BANKRUPTCY IN TWELVE YEARS OF MAKING REDMAN WHEELCHAIRS. PT OBTAINED A DUN AND BRADSTREET CREDIT REPORT WHICH SHOWED THEY WERE NOT IN FINANCIAL DIFFICULTY, AND THAT REDMAN POWER CHAIRS LISTED ITS BUSINESS AS "INTERIOR DESIGN SERVICES". PT ALSO LEARNED FROM A DEPOSITION THAT REDMAN FORMED ANOTHER CO TO GET AROUND THE FACT THAT THEY WERE NOT LICENSED BY FDA TO MFR OR SELL ELECTRIC WHEELCHAIRS. THEY STARTED THIS NEW CO CALLED PACIFIC WESTERN DEVICES IN OCTOBER 1999. THEY ALSO FOUND A CO CALLED MEDI-CHAIR TO HELP THEM SELL CHAIRS TO THE VETTERANS ADMINISTRATION. IT WAS SAID THAT REDMAN WOULD BUY BACK REDMAN POWER CHAIRS, LLC FOR UP TO $300,000 THROUGH MEDI-CHAIR. REDMAN PAID ALL THAT MONEY PLUS ATTORNEYS FEES TO ESCAPE PAYING PT'S CLAIM FOR $50,000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDMAN POWER CHAIR POWER WHEELCHAIR (STANDING, RECLINING/ LEG ELEVATING) ITI PACIFIC WESTERN DEVICES & REDMAN POWER CHAIRS, LLC CHIEF 107 SR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R