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

Model Number M4735A

Device Problem Poor Quality Image (1408)

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

Event Date 10/02/2023

Event Type  malfunction  

Event Description

This report is based on information provided by authorized service personnel (asp) and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart xl defibrillator/monitor indicating that the display was not clear.Available details indicate that the devices display was not clear and that this was a malfunction of the bezel assembly, which was replaced, and the device was returned to full functionality.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 malfunction of the bezel assembly.The reported problem was confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.An analysis was performed by a vigilance reporting specialist (vrs).The vrs determined that while no harm was alleged, recurrence of this failure mode during clinical use could cause or contribute to death or serious injury.Therefore, this failure mode meets the definition of a reportable malfunction.Appropriate regulatory reporting actions have been taken.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 customer replaced the bezel assembly to resolve the 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.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: 17897089
• MDR Text Key: 325721149
• Report Number: 3030677-2023-03997
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K021453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2011
• 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