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 efficia dfm100 defibrillator/monitor indicating ta frequent rfu "x" occurrences.Based on the information available, it was determined that this was a malfunction of the dfm100 assy processor, which was replaced, along with 3 lead ecg cable and trunk cable and the device was returned to full functionality.The device remains at the customer site and no further evaluation is warranted at this time.This complaint investigation has been impacted by logistical limitations associated with the service parts supply chain (sps) returns process.This limitation is beyond the immediate control of the complaint handling group.No further investigation of the component is possible until the limitations are resolved.Based on the information available and the testing conducted, the cause of the reported problem was a malfunction of the dfm100 assy processor.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 is 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 replaced the dfm100 assy processor to resolve the issue.It has been concluded that no further action is required at this time.

Manufacturer Narrative

The dfm100 assy processor (s/n (b)(6)) as returned to philips for additional analysis.The complaint was escalated for technical complaint investigation and the results indicate that there was no fault found with the assy processor.The assy processor passed all performance testing.Based on the information available and the testing conducted, there was no fault found with the assy processor.The reported problem was not confirmed.

• 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: 17703686
• MDR Text Key: 322892856
• Report Number: 3030677-2023-03565
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 06/04/2024

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?: No
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 05/21/2024
• Supplement Dates FDA Received: 06/04/2024
• 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