MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CODEMASTER XE; DEFIB/MONITOR

Model Number M1724A

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.

Event Description

It was reported to philips that the device did not deliver a shock to a patient during a cardioversion procedure.The external paddles were being used during this incident.The doctors switched to another defibrillator and the patient was successfully cardioverted.There was no negative patient impact.The patient was successfully cardioverted with another defibrillator.

• Brand Name: CODEMASTER XE
• Type of Device: DEFIB/MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: denyse murphy ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 6356013
• MDR Text Key: 68506883
• Report Number: 1218950-2017-01284
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K954957
• 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: 02/03/2017

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: M1724A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 02/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/1995
• 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
• Patient Weight: 100