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

Model Number 866199

Device Problem Disconnection (1171)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to philips that the connection cable for the external paddles was missing.Patient involvement information is currently unknown, but no adverse event.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

It was reported to philips that the connection cable for the external paddles was missing.Device was in clinical use but no reported adverse event.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

Customer resolution and conclusion: multiple attempts were made to obtain the device evaluation, repair, and operational status with no response from the customer.No further information was provided.A supplemental report will be submitted if new information is obtained.H3 other text : multiple attempts were made to obtain the device evaluation, repair, and operational status with no response from the customer.

• Brand Name: EFFICIA DFM100 DEFIBRILLATOR/MONITOR
• 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: 12793182
• MDR Text Key: 281149822
• Report Number: 3030677-2021-15566
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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

• Date FDA Received: 11/11/2021
• 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: 11/03/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/11/2019
• 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