MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CODEMASTER XL; DEFIB/MONITOR

Model Number M1723B

Device Problem Failure to Discharge (1169)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported the device did not discharge on the r wave.There was no report of patient involvement.

Manufacturer Narrative

A follow-up report will be submitted once the investigation is complete.

Manufacturer Narrative

Event Description

The customer reported the device did not discharge on the r wave.There was no report of patient involvement.

• Brand Name: CODEMASTER XL
• Type of Device: DEFIB/MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 4950194
• MDR Text Key: 6633455
• Report Number: 1218950-2015-04084
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K954957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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