MAUDE Adverse Event Report: PHILIPS ELECTRONICS UK LIMITED PHILIPS AVENT SINGLE ELECTRIC BREAST PUMP

Model Number SCF 292

Device Problem Fire (1245)

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

Event Date 04/17/2015

Event Type  Other  

Event Description

On (b)(6) 2015 customer claims she used the pump for approximately 6 months about twice daily.When starting the pump, for about five minutes, the consumer heard a bang and the unit started to smell burnt.A flame approximately 2-3 cm came out of the motor.The consumer blew air on the flame until it was extinguished.

Manufacturer Narrative

Product will be requested to be returned for eval.

• Brand Name: PHILIPS AVENT SINGLE ELECTRIC BREAST PUMP
• Type of Device: ELECTRIC BREAST PUMP
• Manufacturer (Section D): PHILIPS ELECTRONICS UK LIMITED; glemsford ; UK
• Manufacturer Contact: mary ferreira ; 1600 summer st; stamford, CT 06905 ; 2033515949
• MDR Report Key: 4740232
• MDR Text Key: 5703615
• Report Number: 8021997-2015-00002
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• PMA/PMN Number: K052047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SCF 292
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other