[410728]
Motion control, inc. Manufactures and sells class 1 electirc prosthetic devices for upper limb amputees. One the their devices, a controller for "below elbow" amputees, has the option to use a rechargeable battery, mounted inside the prosthesis. This battery is recharged (always while "off the patient") by plugging a battery charger into the a/c wall outlet, and into the access port on the prosthesis. The connection to the a/c wall outlet is made through an a/c wall adapter (i. E low vlotage transformer) that the company purchase directly from global pacific electronics, and is manufactured by spectre, inc. The company purchases the remainder of the battery/charger system from added value technologies, inc. By design, all conncetors within the battery/charger system disallow incorrect inter-connectivity. However, the a/c wall adapters the company received in dec. Of 2004 were the wrong part number (i. E. Off by 1 digit in the 10 digit part number) resulting in an incorrect dimension on the connector that interfaces with the charger. The incorrect dimension on the connector also allowed it to connect 'incorrerctly' to the access port on the prothesis, thus applying 18 volts directly across the rechargeable battery, without benefit of the charger circuitry. The prothesis wearer reports that they incorrectly plugged the a/c wall adapter directly into the access port on their prosthesis, bypassing the charger circuit and that after approximately five hours of charging in this manner, the internal battery exploded, and broke out in flames. The wearer quickly grabbed the prothesis and took it outside and extinguished the flames. No injury to the wearer or anyone else was reported. The incorrect digit in the a/c wall adapter part number is the result of an error on our source control drawing for the part. This error happened when re-specifying the part in nov. 2004. The wearer did not follow instructions properly for charging the battery. The combination of these two mistakes resulted in the problem. The comapny have corrected the source control drawing for the a/c wall adapter and have isolated/reworked all in-house product. The company have recalled, and have sent correct replacements for, the (20) incorrect a/c wall adapters that went to customers, having called/spoken with each customer directly, explaining the dangers of incorrect connection. The company have enhanced clarity of operating instructions for the battery charger end users, and have permanently affixed a label to the a/c wall adapter cord that show clearly the proper inter-connectivity of the battery/charger system. The company will review our sop-01 'engineering change orders' and look for opportunities to refine our methods, so as to minimize the likelhood of repeated errors in our review process. The company have made telephone contact with each customer, and have already recieved (11) a/c wall adapters back from customers. The company will continue to push on our customers to return the remaining (9) units.
Patient Sequence No: 1, Text Type: D, B5