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

Model Number M3535A

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Myocardial Infarction (1969)

Event Date 08/25/2022

Event Type  Injury  

Event Description

It was reported to philips there was no shock delivered on a patient during emergency defibrillation using external paddles.The patient was experiencing a heart attack.Another defibrillator was not used as the patient's heart started again on its own.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, there was no direct adverse event to the patient or user.A philips field service engineer (fse) evaluated the device.The fse found that, when the users pressed the shock button, the paddles were not in contact with the patient¿s skin, therefore, the shock had not been delivered.The users tried to shock with the external paddles, however, the connected paddles were the internal paddles, therefore, the connected paddles (internal) were not in contact with patient¿s skin which explained why no shock had been delivered.There were no ecg monitoring strips or patient event files available for review.The device behavior was reproduced by the fse but it was not an issue of the device, it was user error.The fse explained the event to the customer.No parts were replaced.The device passed all performance assurance tests and was placed back into use with the customer.There was no device malfunction found.

• 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: laura scanlan ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 15327671
• MDR Text Key: 298974727
• Report Number: 3030677-2022-04152
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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

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: M3535A
• Device Catalogue Number: M3535A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 08/31/2022
• 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
• Patient Outcome(s): Life Threatening