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

Model Number M1722B

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The customer reported fault -error code 10, unable to power up.There was no reported adverse pt impact.

Manufacturer Narrative

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

• Brand Name: CODEMASTER XL+
• Type of Device: DEFIB/MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: greg theokas ; 3000 minuteman rd.; andover, MA 01810 ; 6871501978
• MDR Report Key: 4390321
• MDR Text Key: 5305906
• Report Number: 1218950-2014-07831
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/09/2014

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: Other
• Device Model Number: M1722B
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 12/30/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2000
• 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