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

Model Number 866199

Device Problems Break (1069); Fitting Problem (2183)

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

Event Date 12/28/2023

Event Type  malfunction  

Event Description

Philips received a complaint on the defibrillator indicating that a piece of the monitor connection was broken.There was no patient involvement.The official dfm100 defibrillator, model# 866199, is substantially similar to the heart start xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.

Manufacturer Narrative

Reporting address line 1: (b)(6), reporting address state: (b)(6), reporting address postal: (b)(6), reporting institution phone: (b)(6), reporter phone: (b)(6).A follow up report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is based on information provided by philips remote service engineer (rse) and has been investigated by the philips complaint handling team.Philips received a complaint on the dfm100 device indicating that the piece of the monitor connection has broken.The rse evaluated the device remotely and offered the repair quote to the customer.The customer did not indicate accepting the service quote therefore this will be documented as a malfunction the cause of which was not determined.The device remains at the customer site and no further evaluation is warranted at this time.Based on the information available and the testing conducted, the cause of the reported problem was a determined.The reported problem was not confirmed.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.H3 other text: remote support provided/repair quote provided.

Event Description

Philips received a complaint on the efficia dfm100 defibrillator indicating that a piece of the monitor connection was broken.There was no reported patient impact or injury.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.

• Brand Name: EFFICIA DFM100
• Type of Device: XL+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: 18568489
• MDR Text Key: 333538838
• Report Number: 3030677-2024-00323
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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

• Date FDA Received: 01/24/2024
• 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?: No
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/19/2018
• 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