Model Number X SERIES |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Additional product codes: drt, mkj.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 while attempting to treat a patient (age & gender unknown) the device failed self-test for pacer, defib, and ecg.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
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Manufacturer Narrative
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Zoll medical (b)(4) evaluated the device and the reported malfunction was observed but not duplicated.The device was put through extensive testing without duplicating the malfunction.The device's monitor board was replaced as a precaution.The device was recertified and returned to the customer.No trend is associated with reports of this type.
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Search Alerts/Recalls
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