MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX -EMS DEFIBRILLATOR

Model Number M3536A

Device Problem Complete Loss of Power (4015)

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

Event Date 03/02/2023

Event Type  malfunction  

Event Description

This report is based on information provided by philips remote service engineer (rse) and has been investigated by the philips complaint handling team.Philips received a complaint on philips heartstart mrx defibrillator indicating that the power module was allegedly malfunctioning, and not functioning properly.There was reportedly no patient involvement.Upon remote investigation, it was found that the ac power module was faulty and needed to be replaced.However, the ac power module field replacement kit was on backorder, causing a delay in the repair of the device.This complaint investigation has been impacted by logistical limitations associated with the service parts supply chain (sps) returns process.This limitation is beyond the immediate control of the complaint handling group.No further investigation of the component is possible until the limitations are resolved.Based on the information available and the testing conducted, the cause of the reported problem was a malfunction of the ac power module.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.Philips recommended replacing the ac power module field replacement kit to resolve the issue.It has been concluded that no further action is required at this time.If additional information is received, the complaint file will be reopened.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• 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: allison prater ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 16657429
• MDR Text Key: 312460420
• Report Number: 3030677-2023-01356
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838006652
• UDI-Public: 00884838006652
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: M3536A
• Device Catalogue Number: M3536A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/02/2023
• Initial Date FDA Received: 03/31/2023
• 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