FDA Adverse Event
Malfunction
Summary report: N
DETECTO
MDR report key: 20810807
·
Received November 29, 2024
Report
- Report Number
- 20810807
- Event Type
- Malfunction
- Date Received
- November 29, 2024
- Date of Event
- July 24, 2024
- Report Date
- September 6, 2024
- Manufacturer
- CARDINAL SCALE MFG. CO
- Product Code
- FRW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
AT OUR URGENT CARE FACILITY STAFF WERE WEIGHING AN INFANT THAT HAD COME IN TO BE EXAMINED. WHILE PERFORMING THE WEIGHT CHECK THE SCALE USE SWITCHED FROM KILOGRAMS TO POUNDS WHEN THE SCALES UNIT BUTTON WAS ACCIDENTLY PRESSED CAUSING THE SWITCH. THIS LEAD TO A MINOR MED ERROR WITHOUT INJURY TO THE CHILD WHEN THE DOSAGE WAS CALCULATED IN THE WRONG WEIGHT VALUE. THE BUTTON ON THE SCALE SITS PROUD OF THE CASE ON THE DEVICE AND IS EASY TO PUSH IF NOT CAREFUL. ADDITIONALLY WHEN THE MANUFACTURE WAS CONTACTED IT WAS EXPLAINED TO BIOMED STAFF THAT THERE WAS NO WAY TO LOCK THE SCALE INTO EITHER WEIGHT UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2469843 | DETECTO | SCALE, PATIENT | FRW | CARDINAL SCALE MFG. CO | MB130 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose |