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

Model Number M3535A

Device Problem Charging Problem (2892)

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

Event Date 09/14/2022

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

The customer reported when doing the actual defib, the charge button is not lighting up.The device was reported to be in use, however, no direct adverse event to the patient or user was reported.Additional details have been requested.

Manufacturer Narrative

The fse evaluated the device on site.The field service engineer performed functionality testing and confirmed that the device was fully functional.The device remains at the customer site and no further evaluation is warranted at this time.The field service engineer explained that between the charge and shock buttons, only the shock button contains a light.The device was tested and returned to service.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.The customer's device was tested and returned to service.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.

Event Description

Statement of the reported problem: this report is based on information provided by the local philips biomed and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart mrx monitor/defib indicating that the charge button was not lighting up during functionality testing.There was reportedly no patient involvement.Functional testing: the fse evaluated the device on site.The field service engineer performed functionality testing and confirmed that the device was fully functional.The device remains at the customer site and no further evaluation is warranted at this time.Confirmation: the field service engineer explained that between the charge and shock buttons, only the shock button contains a light.The device was tested and returned to service.Further action decision: based on the information available and results of additional analysis, no further action is necessary at this time.Trending statement: 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.Closure & product disposition: the customer's device was tested and returned to service.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 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: heidi fraley ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 15595073
• MDR Text Key: 302870519
• Report Number: 3030677-2022-04599
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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 Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• 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