MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX MONITOR/DEFIB; RECHARGEABLE PROFESSIONAL AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number M3535A

Device Problem Naturally Worn (2988)

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

Event Date 04/11/2024

Event Type  malfunction  

Event Description

Philips received a complaint on the heartstart mrx that it is necessary to replace a grabber 3-lead cable as it is worn out.There was no patient involvement.The customer worked with the rse.The customer verified that the 3 lead grabber set is worn out.A new cable set was shipped to the customer for their installation.Based on the information available the cause of the reported problem was a worn out 3 lead cable set.The reported problem was confirmed.No further action is required at this time.

• Brand Name: HEARTSTART MRX MONITOR/DEFIB
• Type of Device: RECHARGEABLE PROFESSIONAL AUTOMATED EXTERNAL 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: 19187690
• MDR Text Key: 341375581
• Report Number: 3030677-2024-01525
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K031187
• 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: M3535A
• Device Catalogue Number: M3535A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/25/2024
• 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