MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC EFFICIA DFM100; DEFIBRILLATOR

Model Number 866199

Device Problem Defective Component (2292)

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

Event Date 02/21/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

It was reported to philips that there were problems with the paddles.There was no patient involvement.

Manufacturer Narrative

This report is based on information provided by philips field service personnel and has been investigated by the philips complaint handling team.Philips received a complaint indicates that paddle connector was broken.There was no patient involvement.The customer requested that a philips field service engineer (fse) be dispatched to the customer site.Fse performed tests.Based on the information available and the testing conducted, the cause of the reported problem was broken paddle connector.The reported problem was confirmed 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 device was operational after cleaning and fixing the paddle connector.The device successfully passed all required testing.The device remains at the customer site and no further evaluation is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: EFFICIA DFM100
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; nanshan district; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; nanshan district; bothell WA 98021
• Manufacturer Contact: jacqueline nishino ; 22100 bothell everett highway; nanshan district; bothell, WA 98021 ; 9095703538
• MDR Report Key: 16587424
• MDR Text Key: 311755414
• Report Number: 3030677-2023-01200
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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 Health Care Professional
• Type of Report: Initial,Followup

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?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/29/2023
• 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