MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX AIRWORTHY

Model Number 861464

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported to philips that the customer had purchased a damaged device from a third party.The customer wanted to open an account in case they needed to send the device in for repairs.

• Brand Name: HEARTSTART MRX AIRWORTHY
• Type of Device: HEARTSTART MRX
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: bethany glynn ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7832408
• MDR Text Key: 118747809
• Report Number: 1218950-2018-07018
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/08/2018

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: 861464
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2010
• 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