Model Number ZM-541PA |
Device Problems
Overheating of Device (1437); Device Inoperable (1663); Temperature Problem (3022); Device Handling Problem (3265)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/11/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that the transmitter gets very warm and has intermittent signal loss.The device was returned to nihon kohden, evaluated, and the reported issue was not confirmed.When the transmitter was received and evaluated, it did not overheat after 5 days of testing.Further testing of the electronics will be performed.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 when additional information becomes available.
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Event Description
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The customer reported that the transmitter gets very warm and has intermittent signal loss.
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Manufacturer Narrative
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The customer reported that the transmitter gets very warm and has intermittent signal loss.The device was returned to nihon kohden, evaluated, and the reported issue was not confirmed.When the transmitter was received and evaluated, it did not overheat after 5 days of testing.An evaluation was performed by nkc and it was confirmed that the unit does not overheat when batteries are installed.The unit has damage to the battery springs.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.
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Search Alerts/Recalls
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