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

Model Number M4735A

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported the heartstart xl monitor / defibrillator shocked a patient during an operational check.We are considering this to be a serious injury as it is unknown if this issue occurred during treatment and it is unknown if the patient required additional treatment.Additional information has been requested.

Manufacturer Narrative

This case has been determined to be a non-adverse event/malfunction.

Event Description

The customer reported the heartstart xl monitor / defibrillator shocked a patient during an operational check.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.

• Brand Name: HEART START XL
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: laura scanlan ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 9182966
• MDR Text Key: 162653455
• Report Number: 1218950-2019-07773
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K001725
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2010
• 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