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

Model Number M04743A

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported the device had damaged paddles.There was no reported pt involvement.

Manufacturer Narrative

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

• Brand Name: SWITCHED INTERNAL PADDLES -4.5
• Type of Device: LDD, MKJ, DQA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810 109
• Manufacturer Contact: nancy ataide ; 3000 minuteman rd.; andover, MA 01810-1099 ; 9786597429
• MDR Report Key: 4214185
• MDR Text Key: 17993286
• Report Number: 1218950-2014-04568
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M04743A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2009
• 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