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

Model Number 866199

Device Problem No Audible Alarm (1019)

Patient Problems Unspecified Heart Problem (4454); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  malfunction  

Event Description

It was reported to philips that the device did not alarm when patient went into ventricular fibrillation.We are considering this event to be a serious injury based on the report that the treatment was interrupted requiring the use of another 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.

Manufacturer Narrative

(b)(6).A follow up report will be submitted upon completion of the investigation.

Manufacturer Narrative

Based on the information available and the testing conducted, the cause of the reported problem was due to ambu ecg dots.The reported problem was confirmed.Based on the information available, ambu ecg dots are replaced with 3m dots which fixed 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 ambu ecg dots are replaced with 3m dots.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

Correction: this report has been updated from serious injury to product problem philips received a complaint on the efficia dfm100 defibrillator indicating that device did not alarm as expected.It was reported the patient was observed to be in ventricular fibrillation (vf) by the clinical team.The patient was defibrillated appropriately and in a timely manner.There is no indication that the reported device event interfered with treatment of the patient.Therefore, this event does not meet the criteria for serious injury.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 remote service personnel and has been investigated by the philips complaint handling team.Based on the information available and the testing conducted, the cause of the reported problem was due to incompatible 3rd party ambu ecg electrodes.The reported problem was confirmed.Based on the information available, incompatible 3rd party ambu ecg electrodes are replaced with 3rd party 3m electrode pads which fixed the issue.The device was operational after incompatible 3rd party ambu ecg electrodes are replaced with 3rd party 3m electrode pads.The investigation concludes that no further action is required at this time.H3 other text : device evaluated by remote service personnel.

• 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: 16076860
• MDR Text Key: 306405684
• Report Number: 3030677-2022-05864
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/30/2022
• 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: 03/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/25/2018
• 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