Model Number 799-AEB1-00-01 |
Device Problem
Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
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Event Description
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Complainant alleged that during incoming inspection, the device displayed an unknown "internal comm" error message.Complainant indicated that there was no patient involvement in the reported malfunction.
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Manufacturer Narrative
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This supplemental medwatch report is reporting the evaluation of the device.This supplemental medwatch report is also updating information submitted on the initial medwatch report.Please reference section b5.Evaluation results: the customer's report was observed during intial tesing of the device.However, the device was put through extensive testing without duplicating the report.A system interconnection cable was replaced and the calibration table was reloaded as a precaution.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
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Event Description
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Complainant alleged that during incoming inspection, the device displayed an "internal comm failure 1474" error message.Complainant indicated that there was no patient involvement in the reported malfunction.
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Search Alerts/Recalls
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