MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CODEMASTER XL; LDD, MKJ, DQA

Model Number M1723B

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

During routine maintenance, the customer noted a defect with the codemaster xl battery (m1758a, lot/serial unk).There is no indication of pt involvement.

Manufacturer Narrative

(b)(4).

• Brand Name: CODEMASTER XL
• Type of Device: LDD, MKJ, DQA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: nancy ataide ; 3000 minuteman rd.; andover, MA 01810 ; 9786597429
• MDR Report Key: 4333250
• MDR Text Key: 21724546
• Report Number: 1218950-2014-05777
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 06/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• 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: 06/18/2013
• Was Device Evaluated by Manufacturer?: Yes
• 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