Block a1, a2 and a4 : patient information not currently available.Block d4: udi (b)(4).Ge healthcare investigation is ongoing.A follow up report will be submitted when the investigation has been completed.Legal manufacturer: hcs research park - 9900 innovation drive usa wauwatosa, wi 53226.
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Block g1: contact email changed and email updated.Investigation findings: the reported issue was caused by a thermal runaway due to the sudden internal short circuit within a cell of the totex battery.This resulted in the mac vu360 exploding.Consequently, a patient was struck in the right eye by debris.The patient was treated for the injures in the emergency room and examined by a clinician from an eye clinic which it was reported, the injures did not appear to be serious.Details of the medical treatment were not provided to gehc.This incident is unique to gehc as no other similar incidents have been reported.Based on the investigation, there is no evidence of design deficiency of the device identified.
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