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

Model Number M1722B

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported the device is taking a long time to turn the battery led from the amber to green.There was no report of pt involvement.

Manufacturer Narrative

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

• Brand Name: CODEMASTER XL+
• Type of Device: DEFIB/MONITOR, LDD, MKJ, DQA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman rd.; andover, MA 01810 ; 9786593679
• MDR Report Key: 4407034
• MDR Text Key: 5165868
• Report Number: 1218950-2015-00032
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• 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: 12/11/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2000
• 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