The customer reported that the transmitter's battery contacts had melted.The device was sent in for qa evaluation.The batteries required for this investigation were not returned.However, an inspection of the battery contacts showed that the contacts were incorrectly positioned, creating a situation that could result in shorting and thus overheating.No patient harm was reported.They were provided with an exchanged transmitter.
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H10: additional narrative: on (b)(6) 2018, (b)(6) at (b)(6) reported the transmitter (zm-541pa sn:(b)(6)) had melted plastic near the battery contacts.The nurse informed him that she smelled something burning and took the transmitter off the patient and saw it was melted near the contacts.The patient and nurse were not harmed.Batteries were thrown away.Service requested: exchange service performed: exchange investigation result: the device has been in service since 2017, which is almost 1 year at the time of reported issue.A review of the device history found no previously reported issues with the unit.A review of customer's complaints found no similarly reported issues with a transmitter overheating.Qa evaluation; the batteries required for this investigation were not returned.However, an inspection of the battery contacts shows that the contacts were incorrectly positioned creating a situation that could result in shorting and thus overheating.The root cause is determined to be user error in incorrect repair/positioning of the battery contact.The device was in use with a patient and there was no reported harm.There is no indication of improper or inadequate device design.Based on the given information, this complaint record will be closed.Correction: b1.Adverse event or product problem: adverse event selected incorrectly.Malfunction should be the only selection g4.Date received by manufacturer: should be 02/20/2018 not 03/22/2018 as listed on mdr initial report.
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