MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX AIRWORTHY

Model Number 861464

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to philips that while the customer was performing operational testing, the device had no audio.There was no patient involvement.

• Brand Name: HEARTSTART MRX AIRWORTHY
• Type of Device: HEARTSTART MRX
• 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: 10184976
• MDR Text Key: 196479027
• Report Number: 1218950-2020-03624
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 861464
• Device Catalogue Number: 861464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2011
• 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