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

Model Number 866199

Device Problems Failure to Deliver Shock/Stimulation (1133); Failure to Discharge (1169)

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

Event Date 03/22/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to philips that the defibrillator did not discharge.Device was in clinical use but no reported adverse event.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 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

Based on the information available and the testing conducted, the cause of the reported problem was due to the below defective parts (therapy pca, therapy receptacle, and processor pca).The reported problem was confirmed.Based on the information available, the defective parts are replaced to fix the issue.The device was operational after defective parts are replaced.The investigation concludes that no further action is required at this time.

Manufacturer Narrative

Based on the information available and the testing conducted, the cause of the reported problem was due to the below defective parts.The reported problem was confirmed.Dfm100 assy therapy; dfm100 assy therapy receptacle; dfm100 assy processor.After failure analysis of the defective assy therapy identified that this therapy board failed for pca, open circuit.Based on the information available, the defective parts are replaced to fix the issue.A review of the risk management file was performed and it was determined that this complaint is a reportable malfunction.Regulatory reports have been submitted per regulations.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.The device was operational after defective parts are replaced.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Event Description

This report is based on information provided by philips remote service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the efficia dfm100 defibrillator indicating that device is not delivering the shock.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: 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: 16774277
• MDR Text Key: 313629740
• Report Number: 3030677-2023-01646
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• 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
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2019
• 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): Other