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

Model Number M4735A

Device Problem Naturally Worn (2988)

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

Event Date 12/27/2023

Event Type  malfunction  

Event Description

Philips received a complaint on the heartstart xl defibrillator/monitor indicating that the ecg cables sheath is worn.Available details indicate that the device had exhibited symptoms of a failure.It was determined that this was a malfunction of the 989803145121,3 leadset, snap, iec, icu, 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 989803145121,3 leadset, snap, iec, icu.The reported problem was confirmed.The customer replaced the 989803145121,3 leadset, snap, iec, icu to resolve the issue.It has been concluded that no further action is required at this time.

• 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: 18439665
• MDR Text Key: 331924452
• Report Number: 3030677-2024-00037
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/27/2023
• Initial Date FDA Received: 01/03/2024
• 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