Catalog Number EQ-5000-PT-230V |
Device Problem
Overheating of Device (1437)
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Patient Problem
Superficial (First Degree) Burn (2685)
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Event Date 02/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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Udi section no product information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that overheating of the device occurred, with deformation of the hose.The temperature was being monitored at 44c.Patient suffered 1st degree burns on the upper thorax.No information on any patient treatment or patient details have been provided at this time.
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Event Description
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Additional information : the patient was monitored for an hour and a half.The alarm was working properly while an upper limb thermal blanket was being used.The blanket was fully uncoiled during use.
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Manufacturer Narrative
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Device evaluated by manufacturer, h6 evaluation codes: updated one device was returned for investigation.The device came in bad condition with the membrane switch broken and hose bent badly.The device was tested at temp of 44 degrees and the device was running normal for one hour and stable the entire time.Next, it was tested at 40 and 36 degrees and was also stable through out the time.What was noticed and confirmed, it is that the air flow was very weak, meaning that the filter was completely clogged.A clogged filter may lead to a delay in therapy but not overheating or thermal injury.The reported problem could not be confirmed.No further action was taken.A manufacturing dhr review was not performed because the device is beyond a year from its manufacture date and there was no indication of a manufacturing defect during the investigation.
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Search Alerts/Recalls
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