Model Number M3535A |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Irregular Pulse (2469)
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Event Date 10/28/2020 |
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 the customer performed non-invasive pacing with demand mode for a patient who had low hr (39-40 bpm) and the patient pulse did not increase after pacing.The device was reported to be in use on a patient, causing a delay in possible life threatening therapy/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 the customer performed non-invasive pacing with demand mode for a patient who had low hr (39-40 bpm) and the patient pulse did not increase after pacing.The device was reported to be in use on a patient, causing a delay in possible life saving therapy/treatment and will be considered a serious injury.However, there was no impact to the patient.The customer the philips response center.The customer provided three pictures of strips from the printed event summary.A philips clinician reviewed the event strips.No associated ecg waveforms were provided for review.No information beyond the time of 09:21:46 was available for review.The heartstart mrx allows users to select ma values between 10-175 ma.The highest ma selection was 80 ma.The available information suggests that the patient may have required a higher ma selection than 80 to achieve pacing capture to bring the patient¿s heart rate to the selected rate.However, there is no information about the event after 09:21:46 and there are no ecg strips for the entire event.Therefore, philips is unable to confirm the cause of the reported symptom.The philips authorized channel partner sales engineer visited the customer site and investigated the device.The device tested normal.The device remains with the customer.
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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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