Model Number 799-EMBP-05-01 |
Device Problems
Mechanical Problem (1384); Calibration Problem (2890); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
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Event Description
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Complainant alleged that while attempting to ventilate a patient (age & gender unknown), the device displayed "runtime calibration failure - 1051" and "compressor failure -1001" error messages and inappropriately shut down.Complainant indicated that the clinician obtained another device 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 device was returned to zoll medical corporation for evaluation.The customer's report was attributed to fluid ingress.The customer declined the necessary service required for the device.The device was labeled "not for clinical use" and returned to the customer at their request.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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