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

Model Number 866199

Device Problem Circuit Failure (1089)

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

Event Date 08/21/2023

Event Type  malfunction  

Event Description

Philips received a complaint on the 866199 (efficia dfm100 defibrillator monitor) indicating that the device is booting very slow, specifically the system and when performing the operational check.The event was outside of use and there was no reported patient nor user harm.Available details indicate that the device is booting very slow, specifically the system and when performing the operational check.It was determined component; dfm100 system-on-a-module (som) printed circuit assembly (pca) is faulty and needs to be replaced.The component was ordered and has been shipped to the customer.The faulty component return is expected but not yet received.If the product is returned or additional information is received the complaint will be re-opened and re-evaluated.Device remains at the customer site.Based on the information available and the testing conducted, the cause of the reported problem was faulty component.The reported problem was confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.A review of the risk management file was performed and the potential severity of s3 has been identified in the risk document.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 customer was provided a replacement component to resolve the issue.It has been concluded that no further action is required at this time.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: 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: 17690648
• MDR Text Key: 322734554
• Report Number: 3030677-2023-03534
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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

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
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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