MAUDE Adverse Event Report: AGILENTTECHNOLOGIES, INC. CODEMASTER XL+; LDD, MKJ, DQA

Model Number M1722B

Device Problems Loss of Power (1475); Self-Activation or Keying (1557)

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

Event Type  malfunction  

Event Description

The customer reported that the device shut off by itself, and that it only alarmed for one minute.

Manufacturer Narrative

(b)(4).A f/u report will be submitted upon completion of the investigation.

• Brand Name: CODEMASTER XL+
• Type of Device: LDD, MKJ, DQA
• Manufacturer (Section D): AGILENTTECHNOLOGIES, INC.; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: phyllis mccarthy ; 3000 minuteman rd.; andover, MA 01810 ; 9786592811
• MDR Report Key: 4030246
• MDR Text Key: 17264032
• Report Number: 1218950-2014-04160
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K954957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1722B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2001
• 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