Model Number R SERIES |
Device Problem
Mechanics Altered (2984)
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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 a routine shift check by a clinician, the device was unable to switch modes.Complainant indicated that there was no patient involvement in the reported malfunction.
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Manufacturer Narrative
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The customer's report was verified and attributed to a faulty integrated circuit on the digital board.The digital board was replaced to remedy the report.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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