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

Model Number M4744A

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported to philips "pulp machine damage".This was further clarified by a philips field service engineer as the m4744a internal paddles could not be used.There was no reported pt involvement.

Manufacturer Narrative

(b)(4).

• Brand Name: SMALL SWITCHED INT PDLS
• Type of Device: PHILIPS HEARTSTART INT PDLS
• 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: 4707861
• MDR Text Key: 5662984
• Report Number: 1218950-2015-02061
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K021453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• 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
• Date Manufacturer Received: 03/24/2015
• 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