Device Problems
Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hearing Impairment (1881); Tinnitus (2103)
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Event Type
Injury
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Manufacturer Narrative
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Age ate time of event: 50-60 years old.Date of event: (b)(6) 2018.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 a patient who underwent an mri of the brain reported ringing in one of their ears after their scan.The patient was provided head phones for hearing protection.The patient was seen by a physician who confirmed non-resolving tinnitus.
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Manufacturer Narrative
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H3: the investigation by ge healthcare has been completed.The acoustic performance of the scanner was tested, and it was found to be within regulatory limits.No system issue was found.It is the customers responsibility to provide hearing protection for the patients with a noise reduction rating (nrr) of greater than 29 db as described in the operator manual.The patient was provided hearing protection; however, it was inadequate to protect them from the acoustic noise.Ge reviewed the recommended hearing protection as stated in the operator manual with the customer.No corrections are required as the system was operating within specification.The root cause appears to be inadequate hearing protection.
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Search Alerts/Recalls
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