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

Model Number M3535A

Device Problem Failure of Device to Self-Test (2937)

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

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is completed.

Event Description

The customer reported that the test failed with electrode cable failure message.There was no patient involvement.

• Brand Name: HEARTSTART MRX
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: daniel derochers ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 11100683
• MDR Text Key: 225737663
• Report Number: 1218950-2020-08175
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: (01)00884838000018
• Combination Product (y/n): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/24/2020

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: No Information
• Device Model Number: M3535A
• Device Catalogue Number: M3535A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/24/2020
• Initial Date FDA Received: 12/31/2020
• Supplement Dates Manufacturer Received: 12/24/2020
• Supplement Dates FDA Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2015
• 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