MAUDE Adverse Event Report: LABORIE MEDICAL TECHNOLOGIES CORP PORTASCAN; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2023

Event Type  malfunction  

Event Description

Bladder scanner was not reading correctly and then began reading 999 for every scan and every patient.Broken probe.

• Brand Name: PORTASCAN
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): LABORIE MEDICAL TECHNOLOGIES CORP; 180 international drive; portsmouth NH 03801
• MDR Report Key: 18228718
• MDR Text Key: 329259955
• Report Number: 18228718
• Device Sequence Number: 1
• Product Code: ITX
• 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: 09/29/2023

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2023
• Date Report to Manufacturer: 11/29/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1