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

Model Number M1723B

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A caller center ticket was logged with the following text "paddle broken user was using the device".No pt involvement was reported.

Manufacturer Narrative

(b)(4).

• Brand Name: CODEMASTER XL
• Type of Device: DEFIB/MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman rd.; andover, MA 01810 ; 9786593679
• MDR Report Key: 4713122
• MDR Text Key: 18923278
• Report Number: 1218950-2015-02111
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1723B
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/1997
• 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