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

Model Number 866199

Device Problem Failure to Charge (1085)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

Reporting address line 1: (b)(6).Reporting address state: (b)(6) reporting address postal: (b)(6).Reporting institution phone: (b)(6).Reporter phone: (b)(6).Product support engineering reviewed the received hardware error log and confirmed the reported failure.The fse evaluated the device on site and replaced the processor board in hopes of determining the cause of the issue.However, the charge button on the paddles remained faulty following replacement.The fse then determined the issue was with the golden internal pins having broken off in the receptacle causing a loss of contact from the charge button on the paddles to the defibrillator.The fse replaced the therapy receptacle resolving the reported issue.The device remains at the customer site and no further evaluation is warranted at this time.

Event Description

This report is based on information provided by philips field service engineer (fse) and philips emergency care product support engineering has been investigated by the philips complaint handling team.Philips received a complaint on the efficia dfm100 defibrillator indicating that the user was unable to activate the charge on the paddles that are connected to the defibrillator.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.

• 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: feng she ; no.2 keji north 3rd road; nanshan district; shenzhen ; CH ; 7552698099
• MDR Report Key: 19141182
• MDR Text Key: 340799684
• Report Number: 3030677-2024-01450
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2020
• 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