Of the 4 devices, 4 lot numbers were provided and the lot history reviews were performed.Of the 4 reported malfunctions, devices were not returned for evaluation; however, medical records were provided for all malfunctions.For one malfunction, the investigation is inconclusive for malposition of device and patient device interaction problem.For the remaining three malfunctions, the investigation is confirmed for patient device interaction problem; however, investigation is inconclusive for malposition of device.Based upon the available information, the definitive root cause is unknown.The devices were labeled for single use.(corporate lot no: gfxf3667).
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This report summarizes four malfunctions.A review of the reported information indicates that model md800f vena cava filter allegedly experienced malposition of device and patient device interaction problem.The information was received from various sources.All the four malfunctions involved patients with no patient consequences.Of the four malfunctions, three were female and one was male.Of the four malfunctions, three patient's ages were reported ranging from 42 to 64.The weight of the one patient was (b)(6) lbs.No other patient information was provided.
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