Model Number R SERIES |
Device Problems
Failure of Device to Self-Test (2937); Output Problem (3005)
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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's defib output was out of specification and failed self test.Complainant indicated that there was no patient involvement in the reported malfunction.
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Manufacturer Narrative
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The device was returned to zoll medical corporation for evaluation.The customer's report was verified and attributed to the charging capacitor on the pace/defib (pd) engine board.The pd engine 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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