The biomedical engineer reported that the transmitter's casing was warped, indicating the device was overheating.There was no fluid intrusion reported.The device was not in use on a patient at the time.The biomedical engineer was advised that we no longer do exchanges for this model, however we will repair the device provided the needed parts are available.Nihon kohden is currently waiting for the device to arrive.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
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Corrected data: device available for evaluation, device evaluated by manufacturer, additional manufacturer narrative.Additional information: type of report?: follow up,
type of report: follow up, additional information/correction, event problem and evaluation codes.The biomedical engineer (bme) reported that the transmitter's casing was warped, indicating the device was overheating.There was no fluid intrusion reported.The device was not in use on a patient at the time.The bme was advised that we no longer do exchanges for this model.The device was repaired and returned to the customer.Investigation revealed that the malfunction of the device was due to improper installation of the batteries in the unit.
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