MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART XL+ DEFIBRILLATOR/MONITOR

Model Number 861290

Device Problem Device Alarm System (1012)

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

Event Date 06/16/2023

Event Type  malfunction  

Event Description

This report is based on information provided by the philips field service engineer (fse) and has been investigated by the philips complaint handling team.Philips received a complaint regarding the heartstart mrx, indicating intermittent occurrence of a "check pad connection" message.There was reportedly no patient involvement.The fse evaluated the device on-site.Upon investigation and conducting tests, it has been determined that the issue is caused by bad paddle operation.Furthermore, tests have shown drug penetration into the paddle trays, which exacerbates the problem.Thorough cleaning of the paddles and trays was performed to remove any drug residue or debris that could be causing interference with the pad connection.Based on the available information and conducted testing, it has been confirmed that the reported problem was caused by a malfunction in the paddle operation.Based on the information available and results of additional analysis, no further action is necessary at this time.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.After the cleaning process, the paddle and tray operation returned to normal, resolving the intermittent appearance of the "check pad connection" message.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: HEARTSTART XL+ DEFIBRILLATOR/MONITOR
• 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: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 17303223
• MDR Text Key: 319444741
• Report Number: 3030677-2023-02757
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: 00884838023680
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 861290
• Device Catalogue Number: 861290
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/11/2023
• 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