MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEART START XL; DEFIBRILLATOR

Model Number M4735A

Device Problem Computer Software Problem (1112)

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

Event Date 10/17/2023

Event Type  malfunction  

Event Description

This report is based on information provided by a philips remote service engineer (rse) and has been investigated by the philips complaint handling team.Philips received a complaint on the m4735a (heartstart xl defibrillator/monitor) indicating that the device was issuing a message regarding the configuration parameters in the configuration menu settings is lost.There was reportedly no patient involvement.Remote support was provided, the device was issuing a message regarding the configuration parameter is lost.It was noted that the customer was sent the configuration to reload.The customer was contacted by email from the rse to confirm resolution, there was no response.Additionally, a good faith effort was made to obtain additional information associated with this complaint evaluation, but attempts have been unsuccessful.If additional information is later obtained, the complaint will be reopened.There is no indication of parts replacement.Device remains at the customer site.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.A review of the risk management file was performed and the potential severity of s3 has been identified in the risk document.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.A good faith effort was made to obtain additional information regarding customer resolution associated with this complaint, but attempts have been unsuccessful.If additional information is later obtained, the complaint will be reopened.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.According to service bulletin sb86100166d, the m4735a heart/start xl portable defibrillator/monitor was discontinued on 31-december-2013.All options associated with this defibrillator were discontinued as of 31-december-2013.The end of support date for the device is 31-december-2018.

• Brand Name: HEART START XL
• 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: 18762632
• MDR Text Key: 336968926
• Report Number: 3030677-2024-00714
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K021453
• 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: M4735A
• Device Catalogue Number: M4735A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 02/22/2024
• 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