Model Number 8900-2106-01 |
Device Problems
Compatibility Problem (2960); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
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Event Description
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Complainant alleged that while attempting to treat a patient (age & gender unknown), the device's defib output was out of specification.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
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Manufacturer Narrative
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The device was not returned for evaluation.The data file and visual data from the event was returned and evaluated.A review of the provided data file and visual data showed an impedance load of 175 and a discharge of approximately 290j, which falls within the device specification based on the selected energy + load (patient's impedance) and -/+ 15% accuracy of the target delivery of 260j.After review of the data file and pictures, it was concluded that the resulted outcome is within the expected performance of the device and electrodes.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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