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

Model Number M4735A

Device Problem Crack (1135)

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

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device was evaluated by an authorized service personnel.

Event Description

This report is based on information provided by philips authorized service personnel (asp) personnel and has been investigated by the philips complaint handling team.Philips received a complaint about the heartstart xl, indicating that there was a cracked latch on the adult paddle plate.The device was not in clinical use at the time the issue was discovered, and there was no reported patient impact or injury.The complaint investigation revealed that the reported issue was related to a cracked latch on the adult paddle plate and did not pertain to the electric shock plate itself.Additionally, the device was evaluated by an authorized service personnel (asp) who ordered the efficia paddle electrode plate dfm100 to resolve the issue.Based on the available information and conducted testing, the reported issue was confirmed to be a cracked latch on the adult paddle plate, which made it easy for the paddle plate to detach.Based on the information available and results of additional analysis, no further action is necessary at this time.To resolve the issue, the asp ordered the efficia paddle electrode plate dfm100.The investigation concludes 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: 18447962
• MDR Text Key: 332154557
• Report Number: 3030677-2024-00058
• 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: Other Health Care Professional
• 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: 12/18/2023
• Initial Date FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: No
• 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