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

Model Number 866199

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/02/2024

Event Type  Death  

Event Description

It was reported the device failed to shock when needed for ¿electro-systolic pacing probe¿.The patient died.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

Patient outcome code grid = death.

Event Description

Philips received a complaint on the efficia dfm100 defibrillator/monitor indicating that the device failed to deliver shock on a patient.The patient died.

Manufacturer Narrative

Patient outcome code grid = death.This report is based on information provided by a philips remote service engineer (rse) and has been investigated by the philips complaint handling team.Follow-up finding reveals that the device "was misused by the doctors and paramedics, because the dfm was in demand mode, but the ecg cable was not attached, so there was no training." per dfm100 instructions for use (ifu), "the efficia dfm100 requires a 3- or 5-lead ecg cable and monitoring electrodes as the source of the ecg during demand mode pacing." additionally, "fixed mode training was required, but they didn't know how to program it on the device." the rse reissued instructions to the customer and requested it to be laminated and attached to the device.No service or repairs were performed.The device remains at the customer site.Device history logs and patient event files (pefs) were requested.The received compressed (.Zip) file contained only device history logs.Patient event files were not present in the file.The device history logs received were not associated with the date of this reported event.The received logs were three (3) different events which were all in the pacer mode, the device will not shock in pacer mode.Analysis of the device history logs concludes, no errors found.Multiple requests were made to obtain the device history logs and patient event files associated with this event date, but attempts have been unsuccessful.If additional information is later obtained, the complaint will be reopened.Based on the information available, the cause of the reported problem was attributed to user error.The reported problem was confirmed.A clinical harm review was performed and the cause of the pacing failure is unknown as the patient event file was not received for a conclusive analysis.The issue was attributed to user error, there were no failure that was identified with the device.The investigation concludes 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: 18733312
• MDR Text Key: 335690956
• Report Number: 3030677-2024-00661
• 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 Health Care Professional
• Type of Report: Initial

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: 02/13/2024
• Initial Date FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Death