Additional information: two microsensors were returned and evaluated by the supplier.The supplier's evaluation included a review of quality records, which found that the devices met all manufacturing and quality testing/inspection specifications prior to distribution.The evaluation of the device with serial number (b)(4) found minor bends along the catheter body.The device passed all electronic, noise, linearity/hysteresis, and signal drift tests.Based on their evaluation of the device, the supplier was unable to confirm the reported issue with this instrument.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.Refer to mdrs: (b)(4).For information regarding additional devices reported in this event.
|