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

Model Number M4735A

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to philips that the heartstart xl monitor / defibrillator would not administer shock.Philips is considering this event to be a serious injury because it is unknown if the patient experienced an adverse event, the outcome of the event is unknown, and it is unknown if the treatment was interrupted.Additional information has been requested.

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.

Event Description

It was reported to philips that the heartstart xl monitor / defibrillator would not administer shock.A philips authorized representative evaluated the device.The reported issue was not confirmed.The hospital staff reported to this biomedical engineer that the device symptom was likely caused by user error.No electrocardiogram (ecg) strips or case event file were provided for review.This reporter stated that a patient of unknown age, gender, and weight presented to a hospital¿s emergency department on an unknown date, with presenting signs and symptoms not reported.No relevant medical history, relevant past drug history or relevant concomitant medical products were reported.While in the emergency department, the patient experienced an event with details not reported, that warranted hospital staff to connect the patient to the heartstart xl device via defibrillator pads; brand, model, lot number, and expiration date not reported, attempt a synchronized cardioversion, but the defibrillator would not administer shock.The patient¿s heart rhythm and amount of joules was not reported.Hospital staff then switched to defibrillator paddles; brand, model, and serial number not reported, and administered shock to the patient; the mode of the device, number of shocks attempted, administered, and amount of joules not reported.No relevant laboratory data was reported.It is unknown if the patient¿s arrhythmia was converted into a normal sinus rhythm, and it is unknown if the patient was admitted to the hospital.In order to perform a synchronized cardioversion, the operator must press the button to enable sync mode, use the gain control to adjust the ecg size so that the marker dot appears only once with each r-wave, select the desired energy level, press the charge button or the yellow charge button located on the apex paddles, wait until the current charge has reached the energy level selected and a continuous charge done tone is heard, then press and hold shock (or the paddle buttons).The user must continue to hold shock (or the paddle buttons) until the shock is delivered.The defibrillator shocks with the next detected r-wave (heartstart xl m4735a instructions for use (publication number m4735-91900, edition 7, april 2006, pages 7-6 and 7-7).No parts were replaced.The device passed all performance assurance tests and was placed back into use with the customer.There is no information to support that a malfunction occurred.The available information from this report does not support that this symptom represents a systemic, design, or labeling problem.No further investigation or action is warranted.

• Brand Name: HEART START XL
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9356098
• MDR Text Key: 167409772
• Report Number: 1218950-2019-08851
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K001725
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 11/13/2019
• Supplement Dates FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening