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

Model Number 866199

Device Problems Failure to Discharge (1169); Energy Output Problem (1431)

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

Event Date 04/11/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device does not discharge.Additional details have been requested on 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.

Event Description

Philips received a complaint on the efficia dfm100 defibrillator/monitor device indicating that the capacitor is defective and a new therapy assy needs to be ordered.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

The customer evaluated the device and received remote support from the customer care solution center.Based on the information available, the cause of the reported problem was a defective capacitor and therapy assy.The reported problem was confirmed.The rse informed the customer that the capacitor and therapy assy needed to be replaced and provided the part numbers and pricing for the replacement parts.The investigation concludes that no further action is required at this time.

Manufacturer Narrative

Available details indicate that the device had exhibited symptoms of a component failures.It was determined that this was a malfunction of the dfm100 assy capacitance along with dfm100 assy therapy, which was replaced, 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.The customer replaced the dfm100 assy capacitance along with dfm100 assy therapy to resolve the issue.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.

Event Description

Philips received a complaint on the efficia dfm100 defibrillator/monitor device indicating that the device will not make any discharges.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: 16892648
• MDR Text Key: 314823067
• Report Number: 3030677-2023-01918
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• 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: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2023
• 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