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

Model Number 866199

Device Problems Computer Software Problem (1112); Insufficient Information (3190)

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

Event Date 11/02/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to philips that customer reports a technical malfunction with the aed mode of the device.Patient involvement information is currently unknown, but no reported adverse event.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

Based on the information available, the root cause of reported issue is not able to identify as the device problem was not reproduced.Device is working fine as per manufacturer's specifications.The investigation concludes that no further action is required at this time.

• 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: 18203135
• MDR Text Key: 328895095
• Report Number: 3030677-2023-04654
• 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
• 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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/24/2023
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• 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