It was reported to philips that no shock was released from the device during cardioversion on (b)(6) 2020 (addressed in (b)(4).The customer stated this issue occurred twice during the previous week (exact dates are unknown).This report addressed the first issue which occurred during the previous week (b)(4).The second issue from the previous week is addressed in (b)(4).Additional details have been requested.The device was reported to be in use on a patient, causing a delay in possibly life threatening therapy/treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.
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This complaint is a duplicate of (b)(4) previously reported on mdr number 1218950-2020-06565.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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