MAUDE Adverse Event Report: PHILIPS ELECTRONICS UK LIMITED PHILIPS AVENT DOUBLE ELECTRIC BREAST PUKP

Model Number SCF312

Device Problems Charred (1086); Device Inoperable (1663); Detachment of Device or Device Component (2907)

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

Event Date 03/13/2015

Event Type  malfunction  

Manufacturer Narrative

Product was requested to be returned for evaluation, (b)(6) 2015.

Event Description

On (b)(6) 2015 the customer tried to remove the plug from the wall socket and part of the plug stayed in the socket.An electrician was called to the home to remove the plug from the socket.

Manufacturer Narrative

Dfu clearly instructs customer to check cables before every single use.This adverse is given in order to prevent incidents that cable is damaged (e.G.By bending) and that customer is exposed to unsafe situation by using each cable pictures us attached eval show that cable was handed and that can cause fracture of the insulation.Customer stated that they were aware that cable was damaged and will choose to use it ("cord was starting wear and plastic was thin and had exposed wires.") in this case, customer didn't follow instructions stated in the dfu.

Event Description

(b)(6) 2015, customer claims when she plugged the pump (double electric breast pump) in it popped.

Manufacturer Narrative

Product was requested to be returned for evaluation, 09/04/2015 and 09/16/2015.The device has not been returned.This is the first time that such incident is reported.Without receiving plug and complete product for technical investigation and based only on the description of the customer is not possible to clarify the root cause of the incident.Taking into account that no sparking, excessive temperature or other hazardous situations (e.G.Plug is damaged in such way that hv voltage components become accessible) are reported we can conclude that no safety risk occurred.We will monitor possible new cases and take an action if needed.

• Brand Name: PHILIPS AVENT DOUBLE ELECTRIC BREAST PUKP
• Type of Device: NA
• Manufacturer (Section D): PHILIPS ELECTRONICS UK LIMITED; glemsford, suffolk ; UK
• Manufacturer Contact: nina ruiz ; 1600 summer street; stamford, CT 06905 ; 2033515949
• MDR Report Key: 5141496
• MDR Text Key: 28104104
• Report Number: 8021997-2015-00012
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K052047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Not Applicable
• Type of Report: Followup,Followup
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SCF312
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/14/2015
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other