Model Number 8900-0225-01 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2024 |
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 monitor a 65-year-old male patient, the electrode pads would not adhere to the patient's skin.Complainant indicated that the clinician obtained another set of pads 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 electrode pads were not returned to zoll medical corporation for evaluation.Instead, communication with the customer indicated during investigation the user had attached the pad to the patient's gown (clothing) and when removed from the gown to apply to the skin, the sticky pad material remained adhered to the gown.The instructions for use on the onestep cpr a/a electrodes label calls out the importance of good placement on the patient and states: "apply one edge of the electrode securely to the patient" and "roll the electrode smoothly from that edge to the other.Be careful not to trap any pockets of air between the gel and the skin".Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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