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

Model Number M4735A

Device Problem Complete Loss of Power (4015)

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

Event Date 05/18/2023

Event Type  malfunction  

Event Description

It was reported to philips that the device had no electric power.There was no patient involvement.

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.

Manufacturer Narrative

This report is based on information provided by a philips authorized service person (asp) and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart xl defibrillator/monitor indicating the device had no power.The failure was discovered outside of clinical use.No patient or user harm has been alleged.The device was evaluated onsite by the asp.The asp indicated that upon device power up the "replace battery" error was displayed.Replacing the battery with a known good battery for troubleshooting purposes allowed the device to pass self test and function normally.Customer ordered a third party component to repair the device.The device was not available for additional investigation.Based on the information available and the testing conducted, the cause of the reported problem was a faulty battery.The reported problem was 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 while no patient or user harm was alleged in this case, it is likely that if this failure mode were to reoccur during clinical use it could cause or contribute to a death or serious injury.For that reason, this complaint has been designated a reportable malfunction.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 device was operational after repairs were completed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• 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: jacqueline nishino ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 17111050
• MDR Text Key: 317149394
• Report Number: 3030677-2023-02331
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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 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: M4735A
• Device Catalogue Number: M4735A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/12/2023
• Supplement Dates Manufacturer Received: 05/18/2023
• Supplement Dates FDA Received: 07/18/2023
• 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