Model Number R SERIES |
Device Problem
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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Event Description
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Complainant alleged that during functional testing, the device's defib output was out of specification.Complainant did not indicate that there was any patient involvement in the reported 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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Manufacturer Narrative
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The unit was evaluated by zoll medical singapore.The customer's report was duplicated and attributed to a faulty paced/defib engine board.The unit was deemed beyond economical repair, the device was returned to the zoll singapore sales team not repaired and labeled "not for clinical use".Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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