MATRX LIFE DEFENSE PLUS DEFIBRILLATOR DIODE CLASS I RECALL

MATRX LIFE DEFENSE PLUS DEFIBRILLATOR DIODE CLASS I RECALL is 43% complete, the company says. Of the 1,383 portable defibrillator/monitor/pacers with the malfunctioning diode, roughly 595 are now installed with a properly functioning part. In addition to the malfunctioning diode, 194 of the recalled devices contained a flawed relay that is being addressed in a concurrent Class I recall action; the firm has corrected that problem in approximately 67 machines. The primary reason for the LDP diode-related recall, according to FDA's Enforcement Report, is that "the device will fail to operate in the defibrillation mode if a certain component (the D8 diode located on the high voltage PC board) fails" ("The Gray Sheet" Sept. 27, I&W-9). The diode failure produces an "001" error code in the LDP, which "disables the defibrillation function of the device," FDA says. While Matrx was investigating this recall, it discovered a silicone deposit on a relay in a subset of the recalled devices "that makes turning on the machine difficult or impossible," Matrx explained in a July 23 letter to customers. Until LDPs have been refitted with properly functioning parts, Matrx recommends that customers "maintain a backup defibrillator when using the LDP in case the LDP experiences error code 001 and becomes inoperable as a defibrillator." The company first notified users of the problem and recommended the use of backup units in an April 21 "urgent safety alert." At that time, the company had not determined the cause of the error. A recall letter was sent on July 16 to LDP users informing them of the cause of the malfunction and that the company would begin diode replacement "in every LDP in the field." Corrections may occur either in the field or at Matrx, depending on customer preference. In its July 23 recall letter warning users of the relay problem, Matrx advises that "if a device will not turn on at the first depression of the "on" button," users "should always depress that button several times until the unit does turn on. The unit may not turn on after depressing the "on" button." The letter notes that Matrx is refitting LDP diodes and relays at the same time. Matrx says the diode and relay recalls stemmed from manufacturing processes. To resolve the diode situation, Matrx changed to a supplier that produces an "improved version" of the part. Matrx has maintained its relationship with the relay supplier, which identified and corrected the manufacturing problem. In that case, contaminant silicone present on tools used to make one lot of relay covers migrated to the relay, thus inhibiting the relay function.