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Catalog Number CON-EQ-5000HF-115V |
Device Problems
Gradient Increase (1270); Failure to Sense (1559); Temperature Problem (3022)
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Patient Problem
Partial thickness (Second Degree) Burn (2694)
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Event Date 09/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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Device evaluation results: one level 1 equator blower was returned for investigation in used condition.Wear and tear damage was noted on the following components: membrane switch, top enclosure, and bottom enclosure.Following the visual inspection, the investigator attached a test hose, plugged in the line cord, pressed the green button, and selected the 44 degree option on the keypad.The investigator then ran the device for 20 hours using a test hose and observing the temperature with a digital thermometer which was attached to the end of the hose.The investigator was unable to reproduce the over temperature state reported by the customer.The temperature of the unit did not rise above 43.9 degrees during the test.The device functioned as intended.No fault was found with the device.
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Event Description
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It was reported that during an ophthalmology procedure, the smiths medical level 1 equator blower exceeded the set temperature by three degrees.A gown, sheet, and blanket were covering the skin of the patient.The high temperature resulted in the patient experiencing second degree burns.This was observed about ten minutes into the procedure.The warmer was turned off after the patient temperature, which was being monitored esophageally, began to rise.The patient was treated for the second degree burns.The condition of the patient was being monitored.No further complications were reported in relation to the event.
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Manufacturer Narrative
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Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).
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Search Alerts/Recalls
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