MAUDE Adverse Event Report: VERATHON INC. BLADDERSCAN PRIMEPLUS; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number BLADDERSCAN PRIMEPLUS

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 04/21/2021

Event Type  Injury  

Event Description

Bladder scanner kept popping up with "lost connection" even before contact to patient can be made.Fda safety report id# (b)(4).

• Brand Name: BLADDERSCAN PRIMEPLUS
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): VERATHON INC.
• MDR Report Key: 11805743
• MDR Text Key: 250368858
• Report Number: MW5101270
• Device Sequence Number: 1
• Product Code: IYO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BLADDERSCAN PRIMEPLUS
• Device Lot Number: 121-0054683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention