Device Problems
Thermal Decomposition of Device (1071); Use of Device Problem (1670)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Unique identifier: (b)(4).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 while preparing the room for an mr exam and prior to patient entry, the technologist noticed a small section of the table appeared to be burned.
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Manufacturer Narrative
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H3: the investigation by ge healthcare (gehc) has been completed.The mr system was operating within specifications and all safety mitigating devices were functional when checked by the gehc field engineer.The third-party vendor found no deficiencies in the gems flex coil.The root cause of the incident was misuse by setting up the coil in a way that does not follow cable routing safety warnings as described in the operator documentation.The operator manual and warnings provide that crossing or looping of cables may result in burns to the patient.The mr operator has the final responsibility for the use and placement of the coil set-up and preparation of the patient, prior to starting the mr exam procedure.No further actions are planned by gehc.
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Search Alerts/Recalls
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