MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX-EMS DEFIBRILLATOR

Model Number M3536A

Device Problem Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported to philips healthcare that the heartstart mrx failed to completed etco2 calibration.There was no patient involvement.

Manufacturer Narrative

(b)(4): a follow up report will be submitted upon completion of the investigation.

• Brand Name: HEARTSTART MRX-EMS DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: greg theokas ; 3000 minuteman rd.; andover, MA 01810 ; 9786871501
• MDR Report Key: 4182113
• MDR Text Key: 5157357
• Report Number: 1218950-2014-04519
• Device Sequence Number: 1
• Product Code: MJK
• 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: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3536A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: No
• 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