MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTERNAL INFANT PADDLE SET

Model Number M1744A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported to philips that the connector between the paddles and the switchless internal paddle adapter was tight and difficult to make a connection.There was no reported pt impact.

Manufacturer Narrative

(b)(4).When investigation is completed a follow up report will be sent to the fda.

• Brand Name: INTERNAL INFANT PADDLE SET
• 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: 4548976
• MDR Text Key: 21089849
• Report Number: 1218950-2015-00953
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030417
• 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: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1744A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/22/2015
• 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