Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hearing Impairment (1881); Hearing Loss (1882)
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Event Type
Injury
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Manufacturer Narrative
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Incident date is not known.There are no additional device identification numbers.Ge healthcare's investigation is ongoing.A follow up report will be submitted once the investigation has been completed.Device evaluation anticipated, but not yet begun.
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Event Description
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The customer informed ge healthcare that a patient reported hearing loss after a brain mri.The patient was seen by their physician who confirmed the hearing loss and has prescribed cortisone treatment.The patient was provided ear plugs for hearing protection.
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Manufacturer Narrative
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H3: the investigation by ge healthcare has been completed.The acoustic performance test was performed on the system and concluded that the testing meets the (b)(4) requirements and the osha levels are within the specification for this system configuration.The incident appears to be the result of human medical condition(s).The patient was provided specified hearing protection, however a patients medical conditions may cause sensitivity to acoustic levels that occur during normal clinical scanning.No system issue was found.No corrections are required as the system was operating within specification.
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Search Alerts/Recalls
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