The customer reported that a patient was burned by a avalon us transducer.Yes, device was in use on a patient at the time of the reported issue.Further details about the patient, such as age, height and weight had not been made available at the time of the reporting decision.
|
H10: a field service engineer went onsite to evaluate the device.Additional information was requested specifically regarding if the device failed to work as intended, how the issue was solved and how the device was cleaned and repositioned.No additional information was provided.The instructions for use (chapter: "repositioning transducers") recommend that the clinical staff make sure that the transducer is repositioned at least every three hours to prevent skin irritations.Furthermore it is mentioned that a cleaning or disinfecting agent should not remain on the transducer.Therefore customers are instructed to remove agent residues with a cloth dampened in water before applying a transducer to a patient (ifu chapter: "care and cleaning").No further contact was established by the customer regarding the reported device and issue, and the exact cause and resolution for the problem remain unknown.Due to the lack of available information, a malfunction of the device cannot be ruled out.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
|