MAUDE Adverse Event Report: PHILIPS ULTRASOUND, INC. IE33 DIAGNOSTIC ULTRASOUND SYSTEM; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	8500-0082-01
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The phillips machine was initially functioning properly, and the probe was inserted in to the patient, the patient was then heparinized.Before a complete exam could be performed, the machine shut down and was unable to be turned on/perform with normal function.Eventually after 10 attempts to restart the machine the (b)(4) was able to function well enough to complete an exam.

• Brand Name: IE33 DIAGNOSTIC ULTRASOUND SYSTEM
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 13807906
• Report Number: 13807906
• Device Sequence Number: 13974552
• Product Code: ITX
• UDI-Device Identifier: 00884838025226
• UDI-Public: (01)00884838025226
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 03/03/2022
• Report Date (Section F): 03/03/2022

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: 8500-0082-01
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 03/03/2022