Model Number 799-EGB2-00-01 |
Device Problem
Noise, Audible (3273)
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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 functional testing, the device is making a clicking noise.Complainant did not indicate that there was any patient involvement in the reported malfunction.
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Manufacturer Narrative
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The device was returned to zoll medical corporation.The customer's report was observed during initial testing.However, after disassembling the device to determine root cause, the report was no longer seen.Internal inspection found a loose hardware wedged in the location of the compressor.The origin of the loose hardware could not be determined.All hardware were confirmed to be intact and no damage observed.The loose hardware was removed 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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Search Alerts/Recalls
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