FDA Adverse Event
Malfunction
Summary report: N
PORTASCAN TM 3D
MDR report key: 20189965
·
Received September 11, 2024
Report
- Report Number
- 20189965
- Event Type
- Malfunction
- Date Received
- September 11, 2024
- Date of Event
- April 5, 2024
- Report Date
- April 23, 2024
- Manufacturer
- LABORIE MEDICAL TECHNOLOGIES CORP.
- Product Code
- FEN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- WI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ATTEMPTED TO USE BLADDER SCANNER ON PT. SWITCHED OUT BATTERIES, TRIED TO CHARGE BATTERY WITH DEVICE PLUGGED INTO WALL. TRIED TO TURN ON DEVICE WHILE PLUGGED INTO WALL AND UNPLUGGED AND DEVICE WOULD NOT TURN ON WHEN PUSHING THE "ON" BUTTON.
Description of Event or Problem · 0
ATTEMPTED TO USE BLADDER SCANNER ON PT. SWITCHED OUT BATTERIES, TRIED TO CHARGE BATTERY WITH DEVICE PLUGGED INTO WALL. TRIED TO TURN ON DEVICE WHILE PLUGGED INTO WALL AND UNPLUGGED AND DEVICE WOULD NOT TURN ON WHEN PUSHING THE "ON" BUTTON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1243508 | PORTASCAN TM 3D | DEVICE, CYSTOMETRIC | FEN | LABORIE MEDICAL TECHNOLOGIES CORP. | L005142 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |