MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC. IU22 DIAGNOSTIC ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC

Model Number	8500-0064-02
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Sonographer in antepartum ultrasound stated that the machine was down.Sonographer could not start machine.

• Brand Name: IU22 DIAGNOSTIC ULTRASOUND SYSTEM
• Common Device Name: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 3000 minuteman road; building 4; andover MA 01810
• MDR Report Key: 8114601
• Report Number: 8114601
• Device Sequence Number: 16538905
• Product Code: IYN
• UDI-Device Identifier: 00884838025172
• UDI-Public: (01)00884838025172
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/26/2018
• Report Date (Section F): 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8500-0064-02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/26/2018