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

Model Number 866199

Device Problems Material Integrity Problem (2978); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2023

Event Type  malfunction  

Event Description

It was reported to philips that the efficia dfm100 suffered a fall.There was no reported patient involvement.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 philips field service engineer (fse) personnel and has been investigated by the philips complaint handling team regarding a complaint received about the efficia dfm100, which indicated that the equipment suffered a fall.There was reportedly no patient involvement.Visual inspection and functional testing were conducted by the field service engineer (fse) to assess the equipment's condition after a fall, determining that only the blade connector fastener was broken and recommending its replacement, with a quote to be sent for the necessary service repair.Based on the information available and the testing conducted, the root cause of the reported incident, following numerous tests, has been identified as the sole failure component within the equipment subsequent to its fall: the blade connector fastener.As a result, to ensure the equipment's optimal functionality, it will be imperative to replace this specific part.However, the factors leading to the equipment's fall remain unknown at this time.Based on the information available and results of additional analysis, no further action is necessary at this time.An analysis was performed by a vigilance reporting specialist (vrs).The vrs determined that while no harm was alleged, recurrence of this failure mode during clinical use could cause or contribute to death or serious injury.Therefore, this failure mode meets the definition of a reportable malfunction.Appropriate regulatory reporting actions have been taken.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 resolution was to send a quote for replacing the damaged part, specifically the blade connector fastener, to ensure the equipment's perfect operation.The investigation concludes with no further action required at this time, but the complaint file will be reopened if additional information is received.

• 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 WA ; CH
• Manufacturer (Section G): PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC.; no.2 keji north 3rd road; nanshan district; shenzhen WA ; CH
• Manufacturer Contact: feng she ; no.2 keji north 3rd road; nanshan district; shenzhen ; CH ; 7552698099
• MDR Report Key: 17632732
• MDR Text Key: 322072053
• Report Number: 3030677-2023-03384
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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?: No
• 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: 08/03/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2018
• 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