FDA Adverse Event
Malfunction
Summary report: N
ARJO
MDR report key: 23132238
·
Received September 24, 2025
Report
- Report Number
- 23132238
- Event Type
- Malfunction
- Date Received
- September 24, 2025
- Date of Event
- July 16, 2024
- Report Date
- August 27, 2025
- Manufacturer
- VITALGO INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 0
IT WAS FOUND ON THIS DATE APPROX. THAT THE ARJO TOTAL LIFT RENTAL BED SURFACE CONTROL WASN'T WORKING PROPERLY. ARJO WAS CALLED, THEY INSTRUCTED US TO CHANGE PLUGS TO GET THE CONTROL PANEL TO RESET AND RETRY. IT WAS UNCLEAR AT THAT TIME HOW LONG THE AIR CONTROL WASN'T ON. SKIN WAS CHECKED DURING THAT TIME AND WAS DEEMED OKAY. AFTER THE RESET, THE AIR CONTROL PANEL TURNED ON AND FUNCTIONED PROPERLY. IT WAS FOUND AGAIN PER NSM [NURSING SUPERVISOR/MANAGER], PER RN REPORT THAT THE SYSTEM WASN'T WORKING. PER NSM DURING ROUNDS [DATE REDACTED] PATIENT MAY HAVE EXPERIENCED SKIN ISSUES DUE TO THE AIR NOT WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1641795 | ARJO | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | VITALGO INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Female |