The biomedical engineer reported that the transmitter's battery cover was melted and clinicians noticed a burning smell.Upon visual inspection, the biomedical engineer noticed that the battery contacts were also melted.There was no other physical damage or fluid intrusion reported.The device was in use on a patient, however no patient harm was reported.They sent the device in and it is currently awaiting evaluation.The customer was provided with an exchanged transmitter.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.
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Corrected data : device evaluated by manufacturer.Additional information: follow up, additional information/correction, event problem and evaluation codes.The biomedical engineer (bme) reported that the transmitter's battery cover was melted and clinicians notices a burning smell.Upon visual inspection, the bme noticed that the battery contacts were also melted.There was no other physical damage or fluid intrusion reported.The device was in use on a patient, however no patient harm was reported.They set the device in to nihon kohden for evaluation.The customer was provided with an exchanged transmitter.The cause of the transmitter overheating was due to incorrect battery installation.
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