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

Model Number M4735A

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Cardiomyopathy (1764); Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 06/06/2023

Event Type  Death  

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 the defibrillator will not pace.Patient harm was listed as yes.Additional details have been requested.We are considering this to be a serious injury due to a serious deterioration in the state of health of the patient because life-saving therapy/treatment may have been interrupted/delayed.

Manufacturer Narrative

This report is based on information provided by philips field service engineer (fse) and has been investigated by the philips complaint handling team.The fse evaluated the device on site.No malfunction with the device was determined.The device operates normally, and no repair was required however it was retired since the customer purchased the replacement unit which arrived immediately after the incident.The device remains at the customer site and no further evaluation is warranted at this time.It was determined it was user error, not the equipment.No patient event files were available for review and were deemed not necessary by the customer.Based on the information available and the testing conducted, the cause of the reported problem was unknown.The reported problem was not confirmed.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.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.Patient outcome code grid: patient death.

Event Description

It was reported the defibrillator will not pace.Additional information received via email from the customer indicated the device was in the clinical use when the incident occurred.The patient expired.The patient was a 39 year old male who experienced sudden death, associated with heart failure and biventricular cardiomyopathy with a history of smoking and etoh abuse.The patient had chronic congestion of lung, liver, and kidneys.The report was initially submitted as a serious injury due to a serious deterioration in the state of health of the patient because life-saving therapy/treatment may have been interrupted/delayed; however, this report has been updated to a death.

• 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: 17149303
• MDR Text Key: 317459905
• Report Number: 3030677-2023-02413
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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?: Yes
• 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: 06/06/2023
• Initial Date FDA Received: 06/18/2023
• Supplement Dates Manufacturer Received: 06/06/2023
• Supplement Dates FDA Received: 07/05/2023
• 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
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 39 YR
• Patient Sex: Male