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

Model Number 866199

Device Problem Signal Artifact/Noise (1036)

Patient Problems Myocardial Infarction (1969); Insufficient Information (4580)

Event Date 04/01/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported to philips that the ecg wave was abnormal.The patient was in the emergency room and passed away.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

Complaint evaluation: the customer requested that a philips field service engineer (fse) be dispatched to the customer site.The reported issue was confirmed by the pse (product service engineer) and clinical department due to the poor connection between ecg lead wire and patient during use.According to the frequent switching lead on/off from the hardware logs, it is confirmed that the abnormal ecg waveform was caused by the poor connection between ecg lead cable and patient.In the monitoring mode, the selection on the screen was limb lead (ii lead) from the provided video.The performance of connection between the involved device and cable lead was normal so that the poor connection is from the ecg lead cable and patient.Customer resolution and conclusion: the information of analysis of involved device was provided to the customer.The fse instructed the user on the appropriate situation of connection to resolve the issue.No further investigation or action is warranted.There are some suggestions provided for customer as follow: 1.Please confirm the good connection between the ecg lead cable and patient¿s skin during clinical use.2.Perform the ecg simulator with the involved device to test the function of ecg.3.In the monitoring mode with limb lead, the ecg waveform is normal only using the ecg lead cable, but not pads or paddles.

• 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: 14019472
• MDR Text Key: 288649086
• Report Number: 3030677-2022-01899
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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?: 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 04/01/2022
• Supplement Dates FDA Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2021
• 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): Death