Model Number 781295 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Skin Irritation (2076)
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Event Date 08/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is ongoing on this event.When the investigation is completed a follow-up will sent to the fda.
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Event Description
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Philips received a report from a customer related to a patient heating incident with an intera 1.5t mr system.A patient was scanned for an mri examination.After the examination a large area with skin reddening (15 cm) was observed on the patient's right arm and elbow, with blistering.
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Manufacturer Narrative
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Based on the provided information and test performed on site there is no indication of a malfunction of the mr system or coil used.The reddening and subsequent blistering that was observed on the patient's arm was caused by direct contact with the cable of the head coil.No padding was used and it was reported that no distance could be kept due to the patient's size.Contributing factors observed are: the patient was obese.The thermoregulation of obese patients is known to be impaired.The risk of rf energy-related injuries is higher in patients with impaired thermoregulation.Humidity of the examination room.The total administered whole body rf dose.
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Search Alerts/Recalls
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