MAUDE Adverse Event Report: VERATHON INC. BLADDER SCANNER; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number UNKNOWN

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2017

Event Type  malfunction  

Event Description

Initial bladder scan resulted in 0ml.Rescan with different scanner resulted in 588ml.No patient harm.

• Brand Name: BLADDER SCANNER
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): VERATHON INC.; 20001 north creek pkwy; bothell WA 98011
• MDR Report Key: 6935355
• MDR Text Key: 88821108
• Report Number: 6935355
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR