Model Number 861290 |
Device Problem
Failure to Deliver Shock/Stimulation (1133)
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Patient Problem
No Code Available (3191)
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Event Date 05/19/2020 |
Event Type
Injury
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Manufacturer Narrative
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A follow up report will be submitted upon completion of the investigation.
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Event Description
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It was reported to philips that, during an intervention, the device was unable to shock with internal paddles.Another set of internal paddles needed to be used to treat the patient.The device was reported to be in use on a patient, causing a delay in life-threatening therapy/treatment requiring another device to continue treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.Additional details have been requested.
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Event Description
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It was reported to philips that, during an intervention, the device was unable to shock with internal paddles.Another set of internal paddles needed to be used to treat the patient.The device was reported to be in use on a patient, causing a delay in life-threatening therapy/treatment requiring another device to continue treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.The customer stated the device did not cause or contribute to the event because they had another set of internal paddles.There were no ecg monitoring strips or patient event files available to send to us for review.A non-philips dealer field service engineer evaluated the device and was unable to duplicate the issue.No parts were replaced.The device passed all performance assurance tests and was placed back into use with the customer.The reported malfunction could not be confirmed.Because the problem could not be recreated, the cause cannot be determined.
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Manufacturer Narrative
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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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Search Alerts/Recalls
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