Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hearing Loss (1882); Tinnitus (2103)
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Event Date 06/10/2019 |
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 to ge healthcare that a patient undergoing an mri was scanned for a total of 29 minutes using dba rating 33 earplugs and foam pads alongside his head.The patient completed the scan but when the earplugs were removed, he reported having ringing in his ears and some hearing loss.He was seen by an ent who confirmed hearing loss and tinnitus.Patient is scheduled for a follow up appointment with the ent, but told the customer that the symptoms have improved.
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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 patient 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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