MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX; DEFIBRILLATOR

Model Number M3535A

Device Problems Device Remains Activated (1525); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported to philips that the device experienced repeated functional test failures.As a result the device would lock up and continuously print the test summary until the device was powered off by removing the battery.The device was not in use on a patient.

• Brand Name: HEARTSTART MRX
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS HEALTHCARE - BOTHELL; 22100 bothell-everett hwy; bldg a; bothell WA 98021
• Manufacturer Contact: stohn nishino ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8047103
• MDR Text Key: 126512509
• Report Number: 1218950-2018-08669
• Device Sequence Number: 0
• Product Code: MKJ
• Reporter Country Code: IT
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3535A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2006
• 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