MAUDE Adverse Event Report: VERATHON INC BLADDER SCAN; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Device Problems Failure to Power Up (1476); Low Battery (2584)

Patient Problem No Information (3190)

Event Date 06/14/2015

Event Type  malfunction  

Event Description

Patient required multiple bladder scans overnight for lack of urine output from the foley.The first scan machine did not turn on.When the battery was replaced, the machine still stated low battery.When applied pressure to battery, the machine turned on and bladder scan was completed.Attempted to scan bladder at 0650 but machine did not turn on when pressure was applied to the battery.

• Brand Name: BLADDER SCAN
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): VERATHON INC; 20001 north creek parkway; bothell WA 98011
• MDR Report Key: 4865020
• MDR Text Key: 5866512
• Report Number: 4865020
• Device Sequence Number: 1
• Product Code: ITX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 9 YR