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

Model Number 8500-0064-02

Device Problems Break (1069); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2021

Event Type  malfunction  

Event Description

Unable to get portable ultrasound to work.Keyboard cable pinched and severed caught in articulation mount.Keyboard cable replaced.Routed cable in a better position to prevent recurring issues.

• Brand Name: IU22 DIAGNOSTIC ULTRASOUND SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
• Manufacturer (Section D): PHILIPS ULTRASOUND, INC.; 1 echo dr; reedsville PA 17084
• MDR Report Key: 15401365
• MDR Text Key: 299680176
• Report Number: 15401365
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8500-0064-02
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1