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

Model Number M1722A

Device Problem Energy Output Problem (1431)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported to philips that the codemaster defibrillator delivered 118 joules during verification testing when it should have delivered 100 joules.There was no pt involvement.

Manufacturer Narrative

(b)(4).

• Brand Name: CODEMASTER XL+
• Type of Device: LDD, MKJ, DQA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: denyse murphy ; 3000 minuteman rd.; andover, MA 01810 ; 9786597844
• MDR Report Key: 3958177
• MDR Text Key: 4562383
• Report Number: 1218950-2014-03203
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/14/2014

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: M1722A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/14/2014
• Initial Date FDA Received: 06/06/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/1994
• 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