MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC. IE33 ULTRASOUND SYSTEM; IYO IYN ITX

Model Number 795052

Device Problem Electro-Static Discharge (2149)

Patient Problems Injury (2348); Electric Shock (2554)

Event Type  Other  

Event Description

The customer reported an electric shock when unplugging the system and suffered minor injury.The customer was clinically evaluated and returned to work the same day.

Manufacturer Narrative

(b)(4).The field service engineer performed system leakage and performance testing with in-house technicians and all values were within the normal ranges.The system was working as designed.

• Brand Name: IE33 ULTRASOUND SYSTEM
• Type of Device: IYO IYN ITX
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 22100 bothell everett hwy.; bothell WA 98021
• Manufacturer Contact: joe sparks ; 3000 minuteman road; andover, MA 01810 ; 9786593386
• MDR Report Key: 3805834
• MDR Text Key: 4387401
• Report Number: 3019216-2014-00009
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K030455
• 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: 04/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 795052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2008
• 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