MAUDE Adverse Event Report: PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC. EFFICIA DFM100; XL+DEFIBRILLATOR

Model Number 866199

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Myocardial Infarction (1969); Unspecified Heart Problem (4454)

Event Date 03/19/2023

Event Type  Death  

Manufacturer Narrative

Reporting address state: (b)(6).Reporting address postal: (b)(6).Reporter phone: (b)(6).

Event Description

This report is based on information provided by philips field service personnel and has been investigated by the philips complaint handling team.Philips received a complaint indicates that devices cannot charge during use.Patient expired.Two devices were used on this event, another case (b)(4) split to addressed reported issue on (b)(4).The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.

Manufacturer Narrative

The customer requested that a philips field service engineer (fse) be dispatched to the customer site.Device logs and event summary were exported for further review.Based on the clinical event files provided, the table below identifies the relevant events in each case (9 cases using 2 devices used over a three hour period).To address the issue cited above, there was no indication that the devices were unable to charge to a selected energy, specifically: the majority of instances of ¿not charging¿ were related to the user not pressing the charging button following the selection of therapy energy settings.Multiple instances of shocks being disarmed ¿ either manually by the user , or due to device shutoff by the user.Three instances shows no therapy accessory attached to the patient (pads or external paddles) ¿ the device design prevents charging when there is no indication of contact with the patient.All instances showed device manually turned off by operator.Based on the results of the pef review, it has been determined that the failure to discharge/shock events was due to failure of the user to press the shock button and that the device had been manually turned off by the user.Based on the information available and the testing conducted, the cause of the reported problem was the shock button not being pressed during use.Operational check was performed and device passed the test.The device remains at the customer site and no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: EFFICIA DFM100
• Type of Device: XL+DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.; no.2 keji north 3rd road; nanshan district; shenzhen ; CH
• Manufacturer (Section G): PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.; no.2 keji north 3rd road; nanshan district; shenzhen ; CH
• Manufacturer Contact: cassie xiang ; no.2 keji north 3rd road; nanshan district; shenzhen ; CH ; 7552698099
• MDR Report Key: 16759836
• MDR Text Key: 313476200
• Report Number: 3030677-2023-01616
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K110825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 866199
• Device Catalogue Number: 866199
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2019
• 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
• Patient Outcome(s): Life Threatening