MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CODEMASTER 100; LDD, DRO

Model Number M2475B

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer contacted philips to ask about parts numbers and reported that the "device cracks at 360 joules." there was no pt impact.

Manufacturer Narrative

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

• Brand Name: CODEMASTER 100
• Type of Device: LDD, DRO
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: greg theokas ; 3000 minuteman rd.; andover, MA 01810 ; 9786871501
• MDR Report Key: 3793031
• MDR Text Key: 17579455
• Report Number: 1218950-2014-01913
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K950483
• 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: 03/14/2014

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: M2475B
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/14/2014
• Initial Date FDA Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/1997
• 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