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

Model Number M4743A

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported that the internal paddles don't work and the handles are coming apart.There was no pt involvement.

Manufacturer Narrative

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

• Brand Name: SWITCHED INTERNAL PADDLES -4.5CM
• Type of Device: LDD, MKJ, DQA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810 109
• Manufacturer (Section G): 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: 3810180
• MDR Text Key: 17931642
• Report Number: 1218950-2014-00497
• 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: 01/09/2014

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
• Device Lot Number: 5-2013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2014
• Initial Date Manufacturer Received: 01/09/2014
• Initial Date FDA Received: 02/04/2014
• 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