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

Model Number M1723B

Device Problem Battery Problem (2885)

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

Event Type  malfunction  

Event Description

The customer reported a low battery and it needs to be replaced.There was no reported patient involvement.

Manufacturer Narrative

(b)(4).A follow up report will be submitted once the investigation is complete.

• Brand Name: CODEMASTER XL
• Type of Device: LDD, MKJ, DQA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman rd.; andover, MA 01810 ; 9786597804
• MDR Report Key: 4234747
• MDR Text Key: 19304372
• Report Number: 1218950-2014-05187
• 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: 08/06/2014

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: Health Professional
• Device Model Number: M1723B
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/06/2014
• Initial Date FDA Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/1999
• 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