Model Number R SERIES |
Device Problem
Pacing Problem (1439)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
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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Event Description
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Complainant alleged that while attempting to treat a patient (age & gender unknown), the device was unable to pace.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 not replicated or confirmed.The device was put through extensive testing which included by bench handling and pacer functionality stress testing without duplicating the malfunction.The device was recertified and returned to the customer.The electrode pads that were being used at the time of the reported problem were not returned for evaluation.No trend is associated with reports of this type.
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Search Alerts/Recalls
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