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

Model Number 866199

Device Problems Disconnection (1171); Component Missing (2306)

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

Event Date 08/11/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to philips that the joint located between the therapy connector and the plastic cover is missing.There¿s no reported patient involvement.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 complaint was escalated for technical investigation, and the results indicate that the dfm100 defibrillator's therapy port was not connecting properly; this prompted the replacement of the old port, and subsequent maintenance tests confirmed the functionality of the therapy port.Based on the available information and testing conducted, the cause of the reported problem was determined to be the improper connection of the paddles to the therapy port, which led to the replacement of the old port.The reported problem has been confirmed.The resolution involved restoring the functionality of the therapy port.The device was operational after repairs were completed.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

Philips received a complaint regarding the efficia dfm100, in which the seal between the therapy connector and the plastic shell of the dfm100 defibrillator was found to be missing following its return to the workshop.The device was not in clinical use at the time the issue was discovered, and there were no reported patient impacts or injuries.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 complaint investigation revealed that the dfm100 defibrillator's therapy port was not able to connect properly to paddles because of the missing seal; this prompted the replacement of the old port, and subsequent maintenance tests confirmed the functionality of the new therapy port.Based on the available information, it is unclear if the last bench repair tests were carried out correctly before addressing the seal issue to ensure proper functionality.This missing seal, which was found to be the cause of the reported problem, occurred between the therapy connector and plastic cover and was not re-installed by the bench repair technician before the device was returned to the customer from a previous service call.The resolution involved restoring the functionality of the therapy port.The device was operational after repairs were completed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.Evaluation results code grid is updated into "evr-mof-01- malfunction observed without conclusive finding.

Event Description

This report is based on information provided by philips field service engineer (fse) and remote service engineer (rse) personnel, and it has been investigated by the philips complaint handling team.Philips received a complaint regarding the efficia dfm100, in which the seal between the therapy connector and the plastic shell of the dfm100 defibrillator was reported to be missing following its return from bench repair.The device was not in clinical use at the time the issue was discovered.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: 17687714
• MDR Text Key: 322713271
• Report Number: 3030677-2023-03518
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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

• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 09/05/2023
• Supplement Dates Manufacturer Received: 12/11/2023; 12/11/2023
• Supplement Dates FDA Received: 12/13/2023; 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2021
• 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