MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SWITCHED INTERNAL PADDLES -4.5 CM; DEFIB/MONITOR LDD, MKJ, DQA

Model Number M4743A

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported the internal paddle set did not work.There was no report of patient involvement.

Manufacturer Narrative

(b)(4).

• Brand Name: SWITCHED INTERNAL PADDLES -4.5 CM
• Type of Device: DEFIB/MONITOR 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: 4428396
• MDR Text Key: 5170036
• Report Number: 1218950-2015-00222
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/19/2014

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: M4743A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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