MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CODEMASTER XL+; DEFIB/MONITOR, LDD, MKJ, DQA

Model Number M1722B

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported to the philips healthcare call center that this device "does not do anything." there was no report of patient involvement or adverse patient impact.

Manufacturer Narrative

Pr#: (b)(4).

• Brand Name: CODEMASTER XL+
• Type of Device: DEFIB/MONITOR, LDD, MKJ, DQA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786593679
• MDR Report Key: 4455802
• MDR Text Key: 19088084
• Report Number: 1218950-2015-00302
• 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
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• 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
• Date Manufacturer Received: 12/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/1995
• 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