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 Atrial Fibrillation (1729)

Event Date 03/25/2024

Event Type  Injury  

Event Description

It was reported to philips the patient was diagnosed with atrial fibrillation and was admitted to hospital for observation for synchronous electrical cardioversion.When the doctor ordered synchronous electrical cardioversion, the defibrillator could not discharge and repeated attempts failed, seriously delaying the treatment time.The defibrillator was replaced immediately.The replaced defibrillator could perform synchronous 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 was reported to 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

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

Manufacturer Narrative

This report is based on information provided by philips authorized service provider (asp) and has been investigated by the philips complaint handling team.The device was evaluated by customer only.There was no further information regarding the tests customer performed, and how customer determined the cause.However, customer claimed that the reported problem occurred occasionally and did not find any malfunction.Based on the information available and the testing conducted, the cause of the reported problem was able to confirm.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.H3 other text: the device was evaluated by customer only.

Event Description

Philips received a complaint on the dfm100 indicating that the device failed to discharge during use.Customer used another defibrillator to complete the synchronized electrical cardioversion, there was no patient harm or injury reported to philips.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 was reported to have been interrupted/delayed.

• 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: 19175300
• MDR Text Key: 340957805
• Report Number: 3030677-2024-01502
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/12/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/07/2022
• 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