The biomedical engineer (bme) reported that the transmitter got hot and smoked.They were not able to recover the batteries that were connected to the transmitter so that they could be sent in for a proper investigation.They stated that this was reported by the nurses during the night shift.This was found at set-up and not in patient use.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.The following fields are not applicable (na) to the mdr report: patient information, outcomes of adverse event, revelant test/history, lot number & expiration, implant/explant date, reprocessor name/address, medical products, user facility, device bla number, follow-up type,remedial action.
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Details of complaint: the biomedical engineer (bme) reported that the transmitter got hot and was smoking.This was found at set-up and was not in patient use.Investigation summary: the complaint unit was returned by the customer, and it was evaluated by nk repair center.Nk repair center was unable to duplicate the reported issue.A previous nkc investigation identified that the incorrect insertion of the battery may cause the battery spring terminal to break the coating of the battery, leading to short circuit and eventually heating of the device.The battery used with the complaint was not returned and it could not be confirmed if it was damaged from improper battery insertion.Based on the available information, a definitive root cause could not be identified.However, as the issue occurred when used by the customer and was not duplicated by nk, a possible cause of the issue is improper battery insertion.The operator's manual provides instructions on how to properly insert the batteries on the device.Furthermore, a design change was made to prevent overheating by short circuit caused by improper insertion of batteries (ref (b)(4).The design change has been applied to the following serial numbers: (b)(6) - serial (b)(6) or later (b)(6) - serial (b)(6) or later (b)(6)- serial (b)(6) or later (b)(6) - serial (b)(6) or later.The complaint device zm-531pa sn (b)(6) was made prior to this change.A design change has been implemented to the product to prevent short circuit of the battery during battery insertion.
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