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

Model Number M3536A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/03/2021

Event Type  malfunction  

Event Description

It was reported to philips the device showed an ecg bias error.There was no patient involvement.

Event Description

It was reported to philips the device showed an ecg bias error.There was no patient involvement.A philips field service engineer (fse) evaluated the device.The reported issue was confirmed and traced to a faulty processor pca.The fse replaced the processor pca.The device passed all performance assurance tests and was placed back into use with the customer.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 12537553
• MDR Text Key: 273550330
• Report Number: 3030677-2021-14523
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838006652
• UDI-Public: 00884838006652
• Combination Product (y/n): N
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup

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: 09/03/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 09/14/2021
• Supplement Dates FDA Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1