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

Model Number 8500-0082-01

Device Problems Failure to Power Up (1476); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 02/18/2022

Event Type  malfunction  

Event 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
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 13807906
• MDR Text Key: 287403703
• Report Number: 13807906
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00884838025226
• UDI-Public: (01)00884838025226
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 8500-0082-01
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Sex: Female