Model Number AED3 |
Device Problem
Output below Specifications (3004)
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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 biomed testing, the device's defib output was out of specification.Complainant indicated that there was no patient involvement in the reported malfunction.
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Manufacturer Narrative
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This supplemental medwatch report reports the evaluation of the device.This supplemental medwatch report also corrects information submitted in the initial medwatch report.Please reference section d4, updated serial number from (b)(6).The customer was contacted for the return of the suspect product.The product has not been returned to zoll for evaluation.
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Search Alerts/Recalls
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