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

Model Number 866199

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of consciousness (2418)

Event Date 09/01/2022

Event Type  Injury  

Manufacturer Narrative

Pending.

Event Description

Pacing is not successful and the patient's condition worsens.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.Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.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

This complaint has been deemed a duplicate of pr 2503589 already reported on mdr number 3030677-2022-04723.

Event Description

This complaint has been deemed a duplicate of pr 2503589 already reported on mdr number 3030677-2022-04723.

• 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 WA ; CH
• Manufacturer (Section G): PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC; no.2 keji north 3rd road; nanshan district; shenzhen WA ; CH
• Manufacturer Contact: feng she ; no.2 keji north 3rd road; nanshan district; shenzhen, WA ; CH ; 9095703538
• MDR Report Key: 15585119
• MDR Text Key: 301553670
• Report Number: 3030677-2022-04525
• 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

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 866199
• Device Catalogue Number: 866199
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/12/2022
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 12/05/2022
• 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
• Patient Outcome(s): Required Intervention; Life Threatening