Model Number R SERIES |
Device Problem
Mechanical Problem (1384)
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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 not received the product for evaluation and this complaint is still under investigation.
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Event Description
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Complainant alleged that during a routine shift check by a clinician, the device powered up in the incorrect mode.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 evaluated by a zoll-approved service provider.The customer's report was duplicated and attributed to the digital board.The customer declined the recommended repair of the device.The device was returned to the customer 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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