Model Number ZM-531PA |
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 09/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that the transmitter overheated.No consequence or impact to the patient was reported.The device has been returned to nihon kohden and is awaiting 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.No consequence or impact to the patient was reported.
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Manufacturer Narrative
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Details of the complaint: on 09/24/2019, customer at logansport memorial hospital reported the transmitter (zm-521pa sn: (b)(6)) had overheated.The unit had signs of melting near the right battery contact.Investigation conclusion: 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.No consequence or impact to the patient was reported.
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Search Alerts/Recalls
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