Model Number M3535A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Burn, Thermal (2530)
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Event Type
malfunction
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Manufacturer Narrative
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A follow up report will be submitted upon completion of the investigation.
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Event Description
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A customer reported that a patient was burned with defibrillator pads.Additional information has been requested from the customer.
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Event Description
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A customer reported that a patient was burned with defibrillator pads.After a full review of all available information, it has been determined that superficial soft tissue redness with no treatment is an expected outcome of pad usage.No additional evaluation is needed as skin redness is expected.There was no allegation of a malfunction.The heartstart adult/child pad instructions for use states: "misuse or misapplication of any electrode pad may result in patient burns or ineffective therapy.(note: reddening of the skin is normal.)".
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Manufacturer Narrative
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Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Manufacturer Narrative
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Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Event Description
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A customer reported that a patient was burned with defibrillator pads.The customer reported the patient was in the emergency room and three shocks were delivered at 150, 200, and 200 joules.The customer noted a small area of superficial soft tissue burn from the pads.There was no note of a requirement for treatment.After a full review of all available information, it has been determined that superficial soft tissue redness with no treatment is an expected outcome of pad usage.No additional evaluation is needed as skin redness is expected.There was no allegation of a malfunction.The heartstart adult/child pad instructions for use states: "misuse or misapplication of any electrode pad may result in patient burns or ineffective therapy.(note: reddening of the skin is normal.)".
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Search Alerts/Recalls
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