Model Number ZM-530PA |
Device Problems
Overheating of Device (1437); Temperature Problem (3022)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that the transmitter was overheating and having issues when he attempted to insert the batteries.The customer tried switching out the batteries, but the device was still hot to the touch.The device was not in patient use.The customer sent the transmitter in for a warranty exchange.The exchange was sent to the customer.The issue was resolved.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 was overheating and having issues when he attempted to insert the batteries.
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Event Description
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The customer reported that the transmitter was overheating and having issues when he attempted to insert the batteries.
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Manufacturer Narrative
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Details of complaint: on (b)(6) 2020, customer at (b)(6) medical ctr reported the transmitter (zm-530pa sn: (b)(6) ) was heating up when connected to batteries.The unit was hot to the touch and persisted when batteries were changed.Service requested: exchange.Service performed: exchange/device evaluation.Investigation summary: the root cause of the heat damage is determined to be transmitter design, which 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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Search Alerts/Recalls
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