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); Hearing Loss (1882)
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Event Date 01/11/2019 |
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 a patient who underwent an mri complained of hearing impairment after the exam.The patient was provided hearing protection (head phones) for the exam.The patient was seen by a physician who confirmed hearing loss.Treatment was provided, however the actual treatment is unknown.
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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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