Model Number ZM-541PA |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Issue (2379); Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that the transmitter is giving off inaccurate ecg readings.The customer changed the batteries, leads, and put it on a simulator.The device was returned to nihon kohden for evaluation.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr part 803.56 if additional information becomes available.
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Event Description
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The customer reported that the transmitter is giving off inaccurate ecg readings.
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Manufacturer Narrative
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Complaint details: customer reported that their zm-541pa's ecg was giving incorrect readings.The transmitter was tested with different cables and a simulator, but the issue persisted.Service requested: exchange.Service performed: exchange the customer was sent an exchange unit to resolve the issue.The customer's defective unit was received.Defective unit cannot perform operation channel change.The unit was cleaned and evaluated.It had fluid intrusion and was contaminated.Scrap unit.Investigation result: the root cause of the issue was found to be customer mishandling the unit/customer abuse.Evidence of mishandling can be seen through the device having fluid intrusion.Fluid intrusion affects the device's internal components and can affect the overall function of the unit.Based on the given information, this issue is not suspected to be caused by deficient device or design.Corrected information: device available for evaluation? (date returned).
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Event Description
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The customer reported that the transmitter is giving off inaccurate ecg readings.
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Search Alerts/Recalls
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