Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hearing Loss (1882)
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Event Date 07/25/2019 |
Event Type
Injury
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Manufacturer Narrative
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Unique identifier: udi not required.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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It was reported that two weeks following an mr enterography exam, a patient reported hearing loss.Audiology reports appear to confirm a diagnosis of a new hearing deficit.It is not known if any medical treatment was required.The patient was provided mr safe headphones.
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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 iec 60601-2-33 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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