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

Model Number MD6000K0613

Patient Problem Urinary Retention (2119)

Event Date 01/09/2024

Event Type  malfunction  

Event Description

Patient complained of the need to urinate and attempted to urinate several times over a couple hour period.Rn used porta scan bladder scanner to scan patient.Scan consistently showed around 175ml.The physician was at bedside and scanned the patient's bladder with the ultrasound device which read 700.The nurse placed a foley with 500ml urine.A second rn stated the same thing happened to her patient, the scan showed 225ml and the ultrasound read >700.A foley was placed and 800ml of urine was in foley bag.This machine has been repaired 3 times.Each time it is returned, we have the same issues.The probe was reported to need replacement.After discussion, it has been determined that it is more cost effective to replace the machine.We are obtaining a quote for a replacement.Portascan bladder scanner (b)(6).

• Brand Name: PORTASCAN BLADDER SCANNER
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): LABORIE MEDICAL TECHNOLOGIES CORP.
• MDR Report Key: 18573941
• MDR Text Key: 333723003
• Report Number: MW5150684
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/22/2024

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: MD6000K0613
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White