Model Number ZM-520PA |
Device Problems
Overheating of Device (1437); Temperature Problem (3022)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that the transmitter overheated causing the battery compartment to melt.No patient harm or injury was reported.The device was returned to nihon kohden and the reported issue was duplicated.The failed device will not be repaired, but sent for further evaluation.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.
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Event Description
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The customer reported that the transmitter overheated causing the battery compartment to melt.
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Manufacturer Narrative
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Details of the complaint on (b)(6) 2019, customer at (b)(6) reported the transmitter (zm-520pa sn: (b)(6) battery case melted due to overheating.Investigation summary the root cause of the heat damage is determined to be transmitter design did not foresee possibility of short circuit from incorrect insertion of the battery.Assessment determined that in a worst case scenario, the probability of harm is "unlikely or remote" as the maximum exterior temperature (42.6 c) is below the minimum temperature (44 c) that can cause a burn after prolonged (greater than 5 hours) skin exposure.The overall risk of this complaint is determined to be low.A new design change has been introduced to the transmitter rear case which would add an insulating sheet to prevent short circuit of the battery caused by incorrect battery insertion.
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Event Description
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The customer reported that the transmitter overheated causing the battery compartment to melt.
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Search Alerts/Recalls
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