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

Model Number M4735A

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Injury (2348)

Event Date 11/20/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported to philips the device showed a no shock delivered message during defibrillation of a patient but it looked like the device shocked the patient.The device was reported to be in use on a patient, causing a possible delay in 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.

Manufacturer Narrative

Updated from serious injury to death.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 a 59 year old overweight female with a possible pneumothorax required defibrillation.The users attempted to deliver a shock with the heartstart xl in the aed mode using philips m3713a defibrillator pads.The patient reacted with a muscular response but the printout from the device indicated ¿no shock delivered¿.Another defibrillator and new set of defib pads (brand of both unknown) were used to continue treatment of the patient.The customer questioned whether the weight of the patient may have played a role in the shock not being delivered.The involved patient died.There were no ecg strips available for review.However, the heartstart xl instructions for use (ifu - publication m4735-91900, edition 7, page 12-6) troubleshooting section identifies the possible cause of the reported ¿no shock delivered¿ message to be poor skin contact, where the pads are not properly connected to the patient.The ifu advises users to make sure the pads are applied properly and replace the pads, if necessary.The customer stated the device is functional and remains at the customer site.This report is not consistent with a malfunction but is consistent with an insufficient pads to patient contact during attempted delivery of therapy.

• Brand Name: HEART START XL
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 11015655
• MDR Text Key: 221723802
• Report Number: 1218950-2020-07831
• 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: 11/20/2020

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: 11/20/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Weight: 93