Model Number ZM-521PA |
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 02/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that the transmitter overheated, causing heat damage to the battery compartment.The failed device will be sent in for an exchange.No patient harm or injury was reported.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 heat damage to the battery compartment.
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Manufacturer Narrative
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Details of the complaint on (b)(6) 2020, (b)(6) reported the transmitter (zm-521pa sn: (b)(6) ) overheated while in operation.There was no patient injury or harm.The unit has damage in the battery compartment from the heat damage.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 heat damage to the battery compartment.
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Search Alerts/Recalls
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