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

Model Number M3535A

Device Problem Naturally Worn (2988)

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

Event Date 03/15/2024

Event Type  malfunction  

Event Description

Philips complaint handling team.Philips received a complaint on the heartstart mrx indicating that alternating current (ac) power cable is totally worn.There was no patient involvement.The site clinical engineering worked with the philips rse.The clinical engineer determined the ac cable is worn.A new cable has been ordered to the site for their replacement by the customer.No further action is necessary at this time.

• Brand Name: HEARTSTART MRX MONITOR/DEFIB
• 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: 18969629
• MDR Text Key: 338610037
• Report Number: 3030677-2024-01104
• 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: 03/15/2024
• Initial Date FDA Received: 03/25/2024
• 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