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 Atrial Fibrillation (1729); Unspecified Heart Problem (4454)

Event Date 06/19/2023

Event Type  Injury  

Event Description

It was reported no discharge was issued on the patient in synchronous mode for electrical cardioversion.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

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.

Manufacturer Narrative

This report is based on information provided by a philips remote service engineer and philips field service engineer and has been investigated by the philips complaint handling team.Available details indicate that the device failed to discharge on the patient in the synchronous mode for electrical cardioversion.There was no negative results or impact to the patient as another defibrillator was immediately used.The failed device has been removed from service and remains at the customer site.Replacement device sent to the customer to resolve the issue.The complaint was escalated for technical investigation (log analysis) and the results indicate there were no device hardware error or software error found based on the provided device logs.No errors found with the provided event logs.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.A clinical harm review was performed and as failure to shock occurred 3 times during an emergency cardioversion.Another defibrillator was used to successfully delivery therapy.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.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 customer was provided a replacement device to resolve the issue.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: 17328504
• MDR Text Key: 319237910
• Report Number: 3030677-2023-02807
• 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 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: 06/19/2023
• Initial Date FDA Received: 07/14/2023
• Supplement Dates Manufacturer Received: 06/19/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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