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

Model Number 866199

Device Problem Device Alarm System (1012)

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

Event Date 09/28/2023

Event Type  malfunction  

Event Description

It was reported the device rfu (ready for use indicator) shows x and the alarm sounds.There was no patient involvement.Remote support from the customer care solution center was received, during which the customer re-checked the operation of the device and the rfu had become an hourglass mark resolving the reported issue.Based on the information available, the root cause of the reported problem could not be determined as the issue was resolved when it was re-checked.The reported problem was not confirmed.The device remains at the customer site and no further evaluation is warranted at this time.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

H3 other text : remote support from the customer care solution center was received.

Manufacturer Narrative

Correction: the become aware date and the event date have both been updated from (b)(6)2023 to (b)(6)2023.H3 other text : remote support from the customer care solution center was received.

Event Description

It was reported the device rfu (ready for use indicator) shows x and the alarm sounds.There was no patient involvement.Remote support from the customer care solution center was received, during which the customer re-checked the operation of the device and the rfu had become an hourglass mark resolving the reported issue.Based on the information available, the root cause of the reported problem could not be determined as the issue was resolved when it was re-checked.The reported problem was not confirmed.The device remains at the customer site and no further evaluation is warranted at this time.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: 18023223
• MDR Text Key: 326753022
• Report Number: 3030677-2023-04281
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2024

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: 09/29/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 09/29/2023
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• 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