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

Model Number 866199

Device Problem Battery Problem (2885)

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

Event Date 04/09/2024

Event Type  malfunction  

Event Description

This report is based on information provided by philips field service engineer (fse) and has been investigated by the philips complaint handling team.Philips received a complaint on the efficia dfm100 defibrillator indicating that the battery was aged (over three years or 500 cycles.) there was no 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.

Manufacturer Narrative

(b)(6).The fse evaluated the device on site and confirmed the reported issue.The fse determined this issue was with the battery and replaced the battery to resolve the reported issue.The device remains at the customer site and no further evaluation is warranted at this time.

Manufacturer Narrative

Evaluation result code is updated to "no device problem found" since this battery was aged (over three years or 500 cycles).

• Brand Name: EFFICIA DFM100
• Type of Device: XL+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: 19198995
• MDR Text Key: 341302110
• Report Number: 3030677-2024-01541
• 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
• 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?: No
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/28/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2019
• 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