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

Model Number 866199

Device Problem Output Problem (3005)

Patient Problem Unspecified Heart Problem (4454)

Event Date 11/15/2023

Event Type  Injury  

Manufacturer Narrative

No device malfunction was determined.The customer wanted to know why a shock was deemed unnecessary when a defibrillator was used on a patient in aed mode.They were explained that this is normal.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 not determined.The reported problem was confirmed.The customer was explained the device's behavior is normal.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

This report is based on information provided by the site clinical engineer and has been investigated by the philips complaint handling team.Philips received a complaint on the dfm100 device indicating that the ecg analysis is needed.When the defibrillator was being used in aed mode on a patient, analysis was performed and the waveform was considered a shock indication, but the decision was made that a shock was not necessary¿.The record reports the action to resolve the event was ¿shock was dropped at the physician's discretion in manual mode, not aed mode." defibrillators are life-saving devices, therefore failure to shock/pace will be considered a serious injury due to a serious deterioration of health that may result from a delay or failure to shock/pace.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: 18272114
• MDR Text Key: 329774888
• Report Number: 3030677-2023-04802
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 866199
• Device Catalogue Number: 866199
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2019
• 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
• Patient Outcome(s): Other