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

Model Number M3535A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Atrial Fibrillation (1729)

Event Date 01/04/2018

Event Type  Injury  

Manufacturer Narrative

It was reported to philips that the device did not stay in sync mode after the first shock was delivered during an elective cardioversion.The clinicians performed an asynchronized defibrillation when the second shock was delivered.The customer submitted a medwatch report (b)(4) to the fda, which was forwarded to philips on 08may2018.Biomed reported the following: the data is not stored that far back unfortunately on our devices.I had been meaning to ask (b)(6) if he had the strips from the incident and he is out today but from what i remember, even after the event they were not able to go back in to print the actual strip from the event.All they were able to do at that time was run a test with sync on and see how it looked different on the strip from sync off.The device has passed regular pms and operational checks.It is not configured to stay in sync mode, you would need to repress the button every shock you want the sync on for.I believe this is part of their time out now and there are labels on the defibs now saying something like "do you want to sync".How evaluated (actual, simulator, similar)? reproduced? yes, the device had been configured so that the sync mode turns off after the shock has been delivered.Correct use? no.Evaluation results (if applicable): the device performed as intended.In (b)(6) 2018, a (b)(6) year old female patient was being treated for an elective synchronized cardioversion in the pacu.Electrical cardioversion was first attempted with 20 joules, and the patient remained in atrial flutter/fibrillation.A second attempt was tried with 50 joules, which resulted in the patient going into wide qrs complex tachycardia at a rate of -400 beats per minute.An electrical shock with 100 joules resulted in ventricular fibrillation, chest compressions were done briefly, and she then converted to sinus rhythm with 200 joules off electrical shock.The patient was sedated throughout the entire procedure, and was given vasopressors for hypotension.After the procedure, the patient was awake and responded quite well to questions.She had no complaints and was hemodynamically stable.The team recognized that the patient had been defibrillated vs.Cardioverted during this event.The anesthesiologist and cardiologist explained the course of events to the patient and her family both in the pacu setting and again when the patient was on the floor, offering apology and disclosure.Cardiology reported that the defibrillator design requires it needs to be manually set to synchronize each time a shock is given (¿sync on¿).It was discovered that the team performed a defibrillation and not a cardioversion with the second shock.Relationship between device and incident? the device was used to perform an elective cardioversion procedure.How was device in use? the device was used to monitor and treat the patient during cardiac arrest.Patient condition at time of event (if applicable)? the patient experienced a cardiac arrest and was successfully resuscitated.Patient data evaluation: additional patient characteristics and rhythm strips were requested but were not available.The biomed reported that the device sync mode was configured to turn off after the shock was delivered.How was issue resolved? the customer labeled the device with a reminder to the user to check sync mode status.Where is device now? remains with the customer.What parts replaced/why, if known? none.Corrective action: action necessary, why/why not? no.Any similar capa/fco or sb? no.Philips will not consider this as a malfunction of the device.The device was functioning as the optional configuration to turn sync mode off after the shock was delivered.No further communication was requested and no further communication is indicated.

Event Description

It was reported to philips that the device did not stay in sync mode after the first shock was delivered during an elective cardioversion.The clinicians performed an asynchronized defibrillation when the second shock was delivered.In (b)(6) 2018, a (b)(6) year old female patient was being treated for an elective synchronized cardioversion in the pacu.Electrical cardioversion was first attempted with 20 joules, and the patient remained in atrial flutter/fibrillation.

• Brand Name: HEARTSTART MRX
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: nancy ataide ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7560904
• MDR Text Key: 109807552
• Report Number: 1218950-2018-04676
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M3535A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2008
• 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): Required Intervention
• Patient Age: 93 YR
• Patient Weight: 70