MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC EFFICIA DFM100; DEFIBRILLATOR

Model Number 866199

Device Problem Output Problem (3005)

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

Event Date 02/26/2024

Event Type  malfunction  

Event Description

This report is based on information provided by philips remote service engineer (rse) and has been investigated by the philips complaint handling team.Philips received a complaint on the efficia dfm100 defibrillator indicating that the device is giving an electrocardiogram (ecg) malfunction error.Remote support from the customer care solution was received and it was determined the cause of the malfunction was with the ecg cable being disconnected.The ecg cable was reconnected resolving the reported issue.The device remains at the customer site and no further evaluation is warranted at this time.Based on the information available and the testing conducted, the cause of the reported problem was a disconnected ecg cable.The reported problem was confirmed.The ecg cable was reconnected resolving the reported issue.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: EFFICIA DFM100
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: feng she ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 18798111
• MDR Text Key: 336572039
• Report Number: 3030677-2024-00765
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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

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
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 02/28/2024
• 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