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

Model Number 861290

Device Problems Device Alarm System (1012); Defibrillation/Stimulation Problem (1573)

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

Event Date 07/15/2023

Event Type  malfunction  

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.

Event Description

It was reported to philips that the heartstart xl+ rfu (ready for use) has a red x and its beeping.There was no reported patient impact or injury.

Manufacturer Narrative

This report is based on information provided by a philips remote service engineer (rse) and has been reviewed by the philips complaint handling team.Philips received a complaint regarding the heartstart xl, indicating that it displayed a red x and emitted a beeping sound.The device was in use at the time of the event; however, there was reportedly no patient harm.The issue was resolved by pressing the "check" mark and performing an "operation check" from the menu.The test was successful, and the rfu status returned to the hourglass mark.Based on the available information and conducted testing, the reported problem was confirmed, although the cause could not be determined.The heartstart xl+ displayed a red x and emitted a beeping sound, which was resolved by conducting an 'operation check' from the menu.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 is 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.The issue of the heartstart xl+ displaying a red x and beeping was resolved by successfully completing an "operation check" from the menu, which led the device to return to its normal state with an hourglass mark.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: 17479292
• MDR Text Key: 320671305
• Report Number: 3030677-2023-03143
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: 00884838023680
• 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 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
• Device Operator: Health Professional
• Device Model Number: 861290
• Device Catalogue Number: 861290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 07/15/2023
• Supplement Dates FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/03/2014
• 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