Model Number EQ-5000 |
Device Problem
Temperature Problem (3022)
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Patient Problems
Partial thickness (Second Degree) Burn (2694); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2021 |
Event Type
Injury
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Event Description
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It was reported the device was in use with patient during surgery (laparoscopic prostatectomy) with the device temperature setting of 44 degrees c.The patient showed swelling at the chest, neck and arms: the day after surgery blisters appeared (second degree burn).No intervention was determined necessary.According to reporter, "no signs of thermal injury were noted during the operation, but inspection was limited due to patient positioning, surgical drapes, and the warming blanket itself." no adverse effects reported.
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Manufacturer Narrative
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Other, other text: additional information received on jun 1rst attached photos of left upper arm with second degree burns blisters.The left side of chest has red marks.Complaint revealed no sheet between the blanket warming and patient, as just a hospital gown was the barrier between the warming blanket.No visual alarm occurred to alert over temperature.The facility reported the presentation of wound is clearly a burn mark that occurred during an operation that lasted over three hours.No prep or adhesive to the area of skin was used.
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Event Description
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Additional information summary in h 10.
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Event Description
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Additional information summary in h 10.
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Manufacturer Narrative
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Other, other text: additional information received on jun 1st attached photos of left upper arm with second degree burns blisters.The left side of chest has red marks.Complaint revealed no sheet between the blanket warming and patient, as just a hospital gown was the barrier between the warming blanket.No visual alarm occurred to alert over temperature.The facility reported the presentation of wound is clearly a burn mark that occurred during an operation that lasted over three hours.No prep or adhesive to the area of skin was used.
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Manufacturer Narrative
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Correction- file is duplicate of 3012307300-2021-01757.No further reports will be filed under file number 3012307300-2021-04355.
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Search Alerts/Recalls
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