MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX; DEFIBRILLATOR

Model Number M3535A

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Injury (2348)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted after philips obtains more information concerning this event.

Event Description

It was reported to philips that no shock was released from the device during cardioversion on (b)(6) 2020.The device was charging but could not deliver a shock after five attempts.The device could be defibrillated only after restarting.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.Additional details have been requested.The customer also stated this issue occurred twice during the previous week (exact dates are unknown).This report addressed the issue which occurred on (b)(6) 2020.The first and second issues which occurred during the previous week are addressed in (b)(4).

Event Description

It was reported to philips that no shock was released from the device during synchronized cardioversion on (b)(6) 2020.The device was charging but could not deliver a shock after five attempts.The device could be defibrillated only after restarting.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.The customer initially stated this issue occurred twice during the previous week, however, those reports were clarified to be duplicates (addressed in (b)(4)).This report addressed the issue which occurred on 19oct2020.The ecg waveforms from the event on october 19, 2020, were reviewed by a philips clinician.When the lead ii ecg waveform was established at 12:06 minutes elapsed time (et), the ecg was biphasic (above and below the baseline) and of low amplitude with ecg noise present.Leads i and iii also showed noise and artifact; the users selected lead i for monitoring.1st charge ¿ 200j: external paddles were placed on and off the patient 4 times within 17 seconds, no energy delivered.2nd charge ¿ 150j: external paddles were placed for 6 seconds, no energy delivered.3rd charge ¿ 150j: external paddles were placed on and off 4 times, no energy delivered.Users cycled the power off, then on.4th charge ¿ 150j: external paddles were placed and sync shock delivered, converting the patient rhythm.Review of the ecg waveform showed a low amplitude biphasic waveform with intermittent noise; the t-waves were of high amplitude.The waveforms provided do not show whether there were r-wave markers during this event, as r-wave markers are not stored in the event summary.Before cycling the power, the users changed the ecg lead being monitored.When the device began monitoring again, the ecg waveform was such that they were able to deliver the synchronized shock to convert the rhythm.This event is consistent with a lead selection issue where r-waves could not be consistently identified by the algorithm to initially allow for cardioversion.The customer requested the event of october 19, 2020, be compared to the event from february 27, 2020.For the february event, philips provided the customer with a letter describing the sequence of events.After successfully delivering the first synchronized shock, subsequent sync shock attempts (approximately 20 minutes later) were not delivered and the event file showed that the charged energies were manually disarmed.Philips cannot determine whether r-waves were consistently identified during either event.In both of these events, the monitoring lead was not optimal for the r-wave detection that is required for successful synchronized cardioversion.The amplitude of the various components of the qrs complex influence the algorithm detection of r-waves.The heartstart mrx instructions for use (ifu) describes how to select an optimal monitoring lead.The heartstart mrx instructions for use (ifu) provides the following information (publication 453564307761, page 57): it is important to select a suitable lead for monitoring so that a qrs complex can be accurately detected.The guidelines for lead selection are as follows: for non-paced patients: qrs complex should be tall and narrow (recommended amplitude > 0.5mv), r-wave should be above or below the baseline (but not biphasic), p-wave should be smaller than 1/5 r-wave height, t-wave should be smaller than 1/3 r-wave height.The heartstart mrx ifu (page 83) provides the following information in describing the steps to deliver synchronized cardioversion: ¿use the lead select button to select pads or a lead from attached monitoring electrodes.The selected ecg source should have a clear signal and a large qrs complex.(see ¿lead selection¿ on page 57.)¿ it also states: ¿confirm that the sync marker appears only with each r-wave.R-wave markers do not always appear at the peak of the r-wave but always appear on the r-wave.Use the lead select button to change leads of the r-wave markers do not appear correctly.¿ a philips certified distributor and service provider evaluated the device and did not reproduce the issue.The logs were analyzed with no errors found.The device passed all performance assurance tests and was placed back into use with the customer.

Manufacturer Narrative

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.

• Brand Name: HEARTSTART MRX
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10764307
• MDR Text Key: 214070227
• Report Number: 1218950-2020-06565
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: (01)00884838000018
• Combination Product (y/n): N
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3535A
• Device Catalogue Number: M3535A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR