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

Model Number M4735A

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is completed.

Event Description

It was reported to philips the device did not deliver a shock with internal paddles.The device was not able to deliver a shock even with an internal paddle change and the customer needed to use another defibrillator to treat the patient.The device was reported to be in use on a patient, causing a 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.

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 the device did not deliver a shock with internal paddles.On (b)(6) 2020, a 75-year-old patient was undergoing surgical aortic valve replacement.The device was not able to deliver a shock even with an internal paddle change and the customer used another defibrillator to treat the patient.The device was reported to be in use on a patient, causing a delay in life saving therapy and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.The customer was contacted for additional information.The customer biomedical engineer confirmed there was no connection between the connector and the paddles.The internal paddles were reported to be philips m1743a switchless internal paddles.Ecg strips were provided and reviewed by a philips clinician.Philips was provided with four one-page pdfs of strips that identify the device serial number printed by hand at the top and showed a passed shift/system check of the device.The strips show a charge to 20j with delivery of 16j at 09:00:12.This energy delivery is within specifications for the test.The customer confirmed this was a test.The strips appear to be consecutive based on the times but are not continuous.The strips further show 5 charges of 50j each.Four of these charged energies were associated with a message that the shock was not delivered and one charge was associated with a message that the charged energy was cancelled.The device was evaluated onsite by a philips field service engineer (fse).The reported symptom was not reproduced during testing.The fse performed 40 successful shocking tests with the internal paddles.The fse determined that the cause of the incident was due to incorrect connection of the intermediate paddle cable (m4740a).The defibrillator and internal paddles were determined to be fully functional and remain at the customer site.

• Brand Name: HEART START XL
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10741961
• MDR Text Key: 213255865
• Report Number: 1218950-2020-06452
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

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: 10/19/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 75 YR