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

Model Number 866199

Device Problem Pacing Problem (1439)

Patient Problems Loss of consciousness (2418); Unspecified Heart Problem (4454)

Event Date 09/01/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to philips that pacing was not successful and the patient's condition worsened.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

Philips received a complaint on the 866199 (efficia dfm100 defibrillator monitor) indicating that the device misrecognized the p-waves when pacing on a patient.The allegation reportedly occurred while in clinical use on a patient, resulting in the patient's condition worsening.The patient repeatedly lost consciousness but recovered.The patient is alive and in good condition.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 pacing was not successful, and the patient's condition worsened.The patient repeatedly lost consciousness and recovered after a while.The clinical engineer in charge of the patient adjusted the pacing output and tried to lead the patient to successful pacing.Additional details have been requested.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

It was reported to philips that pacing was not successful, and the patient's condition worsened.The patient repeatedly lost consciousness and recovered after a while.The clinical engineer in charge of the patient adjusted the pacing output and tried to lead the patient to successful pacing.Additional details have been requested.A follow up report will be submitted upon completion of the investigation.

• 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: 15636942
• MDR Text Key: 302053407
• Report Number: 3030677-2022-04723
• 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
• Type of Report: Initial,Followup,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: 09/21/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 05/16/2023; 08/18/2023
• Supplement Dates FDA Received: 06/01/2023; 08/24/2023
• 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
• Patient Outcome(s): Other