MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS SMALL SWITCHED INT PDLS; LDD MKJ

Model Number M4744A

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported to philips healthcare that the switched internal paddles were damaged.During diagnostics, the paddles performed according to the service guidelines.Mechanical damage of the contact part (delamination of coating) was confirmed.There was no report of pt involvement.

Manufacturer Narrative

Pr#: (b)(4).A follow up report will be submitted upon completion of the investigation.

• Brand Name: SMALL SWITCHED INT PDLS
• Type of Device: LDD MKJ
• 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: 4078344
• MDR Text Key: 4892851
• Report Number: 1218950-2014-03971
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K021453
• 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: 06/16/2014

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: M4744A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2014
• Initial Date FDA Received: 07/08/2014
• Was Device Evaluated by Manufacturer?: No
• 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