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

Model Number	866199
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the pad gel almost fell apart from the foam backing when teared apart during product introduction.There was no patient involvement.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
This report is based on information provided by local philips personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the philips m3716a multifunction adult/child electrode pads radiolucent alleging that a new set of pads opened during a product demonstration had a gel peel issue.The pads (lot 022822-02) were returned to philips for additional analysis.The complaint was escalated for technical complaint investigation and the results indicate that the alleged failure could not be recreated during failure analysis.The pads functioned as expected per design.Based on the information available and the testing conducted, there was no fault found.The reported problem was not confirmed.The customer was provided with replacement pads to resolve the issue.It has been concluded that no further action is required at this time.

• Brand Name: EFFICIA DFM100 DEFIBRILLATOR MONITOR
• Common Device Name: 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 ; 75526980999
• MDR Report Key: 17083564
• Report Number: 3030677-2023-02280
• Device Sequence Number: 6273463
• Product Code: MKJ
• UDI-Device Identifier: 00884838002852
• UDI-Public: 00884838002852
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 866199
• Device Catalogue Number: 866199
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown