Model Number ZM-521PA |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/22/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that the transmitter overheated causing the battery contacts to melt.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 if additional information becomes available.
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Event Description
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The customer reported that the transmitter overheated causing the battery contacts to melt.
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Event Description
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The customer reported that the transmitter overheated causing the battery contacts to melt.
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Manufacturer Narrative
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Details of the complaint: on 11/22/19, customer at (b)(6) hospital reported battery heat damage to the transmitter (zm-521pa (b)(6) ).The battery contacts were melted as well as the plastic around them.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.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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