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

Model Number 866199

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Tachycardia (2095); Unspecified Heart Problem (4454)

Event Date 10/29/2022

Event Type  Injury  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

It was reported the device therapy shock was not delivered to the patient.There was no harm reported.Another device was used to handle the case.Although no direct adverse event to the patient or user was reported, we are considering this to be a serious injury due to a serious deterioration in the state of health of the patient because life-saving therapy/treatment may have been interrupted/delayed.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

This report is based on information provided by philips field service engineer (fse) and has been investigated by the philips complaint handling team.The therapy printed circuit assembly (pca) was replaced to correct the device operation.The therapy pca (part number (pn): 453564489061) with serial number (sn): (b)(6) was returned to philips for failure analysis.The pca was visually inspected for signs of wear, damage, corrosion, or missing components, and no anomalies were found.The pca under test was placed on the test fixture.The device powered up and displayed error message ¿¿therapy disabled due to system failure¿¿ ¿ ¿¿therapy controller error¿¿.A red x symbol in the rfu window indicated the device could not deliver shocks.Troubleshooting revealed that transistor q20 was missing.The transistor was replaced, and the device testing fixture was now able to pass all testing.No patient event files were able to be provided by the user to philips for evaluation.Based on the information available and the testing conducted, the therapy pca was found to be malfunctioning due to a missing transistor.The replacement of the therapy pca resolved the device problem.

Event Description

Philips received a complaint on the efficia dfm100 indicating that the device did not deliver shock.The case was supra ventricular tachycardia.Emergency cardioversion was delivered by another defibrillator and the delay in care was reported to be less than 5 minutes.Although no harm was reported by the user, given the reported clinical scenario, the reported device event will be considered an adverse event because live-saving therapy/treatment was not available, interrupted, or delayed and may have led to a deterioration in the state of the health of the patient.No harm was reported by the user.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: 17620176
• MDR Text Key: 321919759
• Report Number: 3030677-2023-03347
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: IZ
• 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 Health Care Professional
• 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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 08/11/2023
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2021
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 43 YR
• Patient Sex: Female