Device has never been returned for repair; it was sent back once on 9/28/11 for the power supply to be upgraded, but device was operational when returned for upgrade.After upgrade, device was tested and passed all specifications before it was returned to customer.There have been multiple unsuccessful attempts to retrieve the device (from the distributor) and have it returned for analysis.Patient and mother have both testified that the device did not fail during use and operated as specified.There were not any reports that device did not operate as intended and there is no conclusive data or information to suggest the device caused or contributed to the injury.Thermotek was not made aware of any medications the patient may have been prescribed during use of the device.Device was not returned to us.
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Device was pre-programmed @ 43f degrees to provide cold therapy 45 minutes of every hour.Patient followed instructions given.On (b)(6) three days post surgery, pt toes began to feel numb and turned bluish.Patients mother removed the vascutherm device on (b)(6).On may 18th, a call was placed to the doctors office and reported symptoms to a nurse; the nurse instructed to elevate the foot higher; patient complied.On sunday, patient developed a fever and called the doctors office and was told to come to the office the following day (monday).When patient arrived at doctors office on (b)(6), bubble blisters had begun to develop and she was admitted to the hospital ((b)(6)).From that point forward, patient was hospitalized for a significant period of time, and ultimately underwent a series of surgeries, culminating with partial amputations to toes.There have been multiple unsuccessful attempts to retrieve the device (from the distributor) and have it returned for analysis.Patient and mother have both testified that the device did not fail during use and operated as specified.There were not any reports that device did not operate as intended and there is no conclusive data or information to suggest the device caused or contributed to the injury.Thermotek was not made aware of any medications the patient may have been prescribed during use of the device.
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