Model Number 8011-0501-01 |
Device Problem
Failure to Deliver Shock/Stimulation (1133)
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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 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 defibrillate a patient (age & gender unknown) during an open heart surgery, the associated defibrillator failed to discharge using these internal handles.Complainant indicated that the clinician obtained another pair of internal handles to continue treating the patient.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
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Manufacturer Narrative
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The internal handles were returned to zoll medical corporation for evaluation.The reported malfunction was observed intermittently during initial evaluation.However, additional testing, which included shock testing at various joule settings, cable stressing and manipulation but the signal remained constant.The internal handles passed all tests.The internal handles were scrapped.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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