MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEART START XL; DEFIBRILLATOR

Model Number M4735A

Device Problems Failure to Deliver Shock/Stimulation (1133); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Death (1802); Sepsis (2067); Ventricular Fibrillation (2130); Shock from Patient Lead(s) (3162)

Event Date 12/29/2020

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.

Event Description

It was reported to philips the device failed to shock a patient in ventricular fibrillation.The user tried to deliver shock in manual mode using pads many times.Another defibrillator needed to be used causing a delay in treatment of 1 to 1.5 minutes.A shock was delivered with the secondary device, but the patient still died.

Event Description

It was reported to philips the device failed to shock a patient in ventricular fibrillation.The patient had prolonged sepsis requiring extended icu care.Philips defibrillator pads were connected and the user attempted to deliver shocks in the manual mode "many times", but the "shock never reached the patient".The user switched to a different defibrillator after a 1 to 1.5 minute delay, and was then able to shock the patient.The involved patient died.The customer provided five photos of ecg rhythm strips, which were reviewed by a philips clinician.Image 0213 showed one printout of an operational check.Image 0214 showed an ecg strip dated (b)(6), 2020, 10:58:04, with delivery of one shock in the manual mode (104j, 75 ohms, 18a); lightning bolt to indicate delivery of energy; about1 second of pre-shock waveform and 2 seconds of post-shock waveform, both wide complex but different morphology.Image 0215 showed an ecg strip without date, time, or indication of mode; waveform deflections appear regular at about 150 per minute, rounded complexes.Image 0216 showed an ecg strip without date, time, or indication of mode; low amplitude rounded deflections; with an indication for charging to 150j at the bottom of the strip (triangle, upward arrow, 150j selection) but no indication from this strip that the energy was delivered.Image 0217 showed an ecg strip without date, time, or indication of mode with displaying fine vf/asystole.Based on the photos of the ecg rhythm strips, it is not possible to determine if the wave presented is the patient's ecg or was caused by external chest compressions, nor is it possible to determine whether the successful delivery of the energy was from the first or second device.As reported to philips, the defibrillator had been tested on the morning of the event and passed all testing.The device was evaluated by a philips authorized service provider and passed all testing.Philips had previously notified customers, via (b)(4) and its associated field safety notice released 01 apr 2020, that they should remove their heartstart xl defibrillators from use and replace with another model of defibrillator.Philips made multiple requests for additional information, however, some information was not available including the presence or absence of any on-screen alerts/error messages, why the users believed the shock was not delivered (non-conversion of rhythm or shock counter not incrementing upward), pad placement, whether ecg leads were also attached, and skin condition of the patient.Because the reported shock issue could not be replicated, details were limited, the ecg strips provided show successful delivery of one shock, and the defibrillator met all specifications upon testing, philips was not able to determine the cause of the issue.

Manufacturer Narrative

Report originally submitted with cfn# 1218950; the correct cfn# is 3030677.

Event Description

It was reported to philips the device failed to shock a patient who was in the operating room.The patient had prolonged sepsis requiring extended icu care.The patient went into ventricular fibrillation, and philips defibrillator pads were connected.The user attempted to deliver shocks in the manual mode "many times", but the "shock never reached the patient".The user switched to a different defibrillator after a 1 to 1.5 minute delay, and was then able to shock the patient.The involved patient died.Patient/user involvement: was the device being used on a patient at the time of the event, including for the purposes of diagnosis? yes.Was there any adverse event to the patient or user? yes.The patient died.If there was an adverse event, did the device cause or contribute to the adverse event, and how? the customer stated: the malfunction of the device may have affected the outcome of the procedure.On (b)(6) 2021, philips provided the customer a letter based on philips investigation involving five photos of ecg rhythm strips.Based on the photos of the ecg rhythm strips, it was not possible to determine if the wave presented was the patient's ecg or was caused by external chest compressions, nor was it possible to determine whether the successful delivery of the energy was from the first or second device.Philips made multiple requests for additional information; however, some information was not available.Because the reported shock issue could not be replicated, details were limited, the ecg strips provided show successful delivery of one shock, and the defibrillator met all specifications upon testing, philips closed the matter.On (b)(6) 2021, the customer provided philips with five videos of the event (with the next one starting from where the previous one ended).A philips clinician and a philips product support engineer reviewed the provided videos.1.The configured recording of the event begins at 10:57:30, 6 seconds prior to the first charge.The device was charged to 100j and the first shock is initiated at (10:57:36).2.After approximately 4 seconds elapsed time (10:57:40), the device indicated "lataus purettu" understood to mean "charge deactivated/called off".3.The device again began charging to 100j.4.The first shock was delivered at (10:57:49), 104j, 80ohm, 17a.5.Approximately 6 seconds after the first shock (10:57:55), the device was charged to 100j.6.The second shock was delivered at (10:58:04), 104j, 75ohm,18a.7.The device was charged to 100j at (10:58:18).8.Approximately 4 seconds later (10:58:22), the 200j energy setting was selected, followed by the 150j setting.9.The third shock was delivered (10:58:25), 155j, 75ohm, 22a.10.The device was charged to 150j at (10:58:37).11.The fourth shock was delivered at (10:58:54), 150j, 72ohm, 23a.12.Configured recording ended 6 seconds later (10:59:00) and began again 6 seconds prior to the next charge (10:59:06).13.The device was charged to 150j at (10:59:12).14.The fifth shock was delivered at (10:59:28), 150j, 70ohm, 24a.15.The device was charged to 150j at approximately (10:59:33).16.The sixth shock was delivered at (10:59:38), 149j, 79ohm, 24a.17.Configured recording ended 6 seconds later (10:59:42) and began again 6 seconds prior to the next charge (11:00:07).18.The device was charged to 150j at (11:00:13).After approximately 30 seconds, the device strip showed "lataus purettu" (understood to mean "charge deactivated/called off"), the charged energy was disarmed after 30 seconds, as part of expected device behavior.This new information shows instances of automatic disarm.The heartstart xl instructions for use (ifu) describes automatic disarm.The ifu (publication 453564909521 - page 3-13) describes "once charging is complete, the charge tone becomes continuous.Make sure no one is touching the patient or anything connected to the patient.Call out clearly and loudly [?]stand clear.' then press to deliver a shock to the patient.The defibrillator automatically disarms within 30 seconds if you do not press shock." the device was evaluated by a philips authorized service provider and passed all testing.The new videos show instances of automatic disarm, which is per the device's specifications.In addition, philips previously notified customers, via fco86100213 and its associated field safety notice released 01 apr 2020, that customers should remove their heartstart xl defibrillators from use and replace with another model of defibrillator.

Manufacturer Narrative

Report originally submitted with cfn#: (b)(4); the correct cfn#: is (b)(4).

• Brand Name: HEART START XL
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell-everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 22100 bothell-everett highway; bothell WA 98021
• Manufacturer Contact: bethany glynn ; 22100 bothell-everett highway; bothell, WA 98021 ; 9786871501
• MDR Report Key: 11164629
• MDR Text Key: 226628932
• Report Number: 1218950-2021-00233
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K021453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M4735A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 02/09/2021; 09/06/2021
• Supplement Dates FDA Received: 11/02/2021; 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2002
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 50 YR
• Patient Sex: Male