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 Response, Decreased (2271)

Event Type  Injury  

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 that an internal paddle set was used to deliver a shock to a patient.The customer stated it sounded like the device was sending a shock, and the device said "shock delivered", however, no current was sent to the patient.A second internal paddle set was used with the same result.The customer used a third internal paddle set which worked.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.Additional details have been requested.This report addresses the first internal paddle set.

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.H3 other text: the defibrillator was evaluated by the customer biomed and passed all testing.No ecg monitoring strips or case event files were provided to philips for review.The customer biomed confirmed the internal paddle set was faulty.

Event Description

It was reported to philips that an internal paddle set was used to deliver a shock to a patient.The customer stated it sounded like the device was sending a shock, and the device said "shock delivered", however, no current was sent to the patient.The customer stated they believed there was no current being sent to the patient due to the heart was not defibrillated and there were no ecg changes.A second internal paddle set was used with the same result.The customer used a third internal paddle set which worked.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.This report addresses the first internal paddle set.The second internal paddle set is addressed in (b)(4) (mfr.Report #:1218950-2020-05777).

• Brand Name: HEART START XL
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10610334
• MDR Text Key: 209329028
• Report Number: 1218950-2020-05776
• 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: 09/25/2020

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: 09/25/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 09/25/2020
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 77 YR