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.
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The manufacturer previously reported information that there was a speaker malfunction on the mx40 telemetry device.The device was not in use on a patient.Additional information has been received and the device has been returned for evaluation.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.
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