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

Model Number M3536A

Device Problems Accessory Incompatible (1004); Failure to Deliver Shock/Stimulation (1133); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported to philips there were problems with triggering the internal paddles while being used with open heart surgery.Additional details have been requested.The device was reported to be in use on a patient, causing a delay in life saving therapy and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.

Event Description

It was reported to philips there were problems with triggering the internal paddles during testing.This case was originally reported as a serious injury however additional information received via email from the customer clarified that the issue occurred during testing and there was no patient involvement.

Manufacturer Narrative

H3 other text : customer declined service.

Event Description

It was reported to philips there were problems with triggering the internal paddles during testing.The customer declined service from philips.The customer did not respond to requests for information regarding the evaluation of the internal paddles.The heartstart mrx remains with the customer.No conclusion can be drawn.

• 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: elizabeth proctor ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 12408015
• MDR Text Key: 269353853
• Report Number: 3030677-2021-14058
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838006652
• UDI-Public: 00884838006652
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3536A
• Device Catalogue Number: M3536A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/27/2021
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 09/21/2021; 12/10/2021
• Supplement Dates FDA Received: 10/26/2021; 01/07/2022
• 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
• Patient Outcome(s): Required Intervention