ADVANCED CONTROL I-BASE, DC
Report
- Report Number
- 2921578-2024-00012
- Event Type
- Malfunction
- Date Received
- August 6, 2024
- Date of Event
- April 2, 2024
- Report Date
- October 22, 2024
- Manufacturer
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Product Code
- JEA
- UDI-DI
- 00842430106026
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
PER THE INFORMATION OBTAINED FROM DEVICE EVALUATION, IT WAS FOUND OUT THAT THE TABLE HAD ONE LOOSE CASTER, DC POWER CONNECTIVITY PROBLEMS AND SLIGHT RUST OBSERVED ON THE CENTER BEAM. THESE ISSUES WERE FIXED BY MIZUHO OSI SERVICE ENGINEER. THE REASON FOR THE TABLE TILT REMAINS UNCLEAR AS THERE WAS NO EVIDENCE FOUND THAT INDICATED ANY ISSUE WITH THE TILT MECHANISM OF THE TABLE. IT WAS ALSO FOUND OUT THAT THE DEVICE WAS LAST SERVICED BY MIZUHO OSI IN 2019 AND WAS CURRENTLY BEING SUBJECTED TO SERVICE AND MAINTENANCE PROCESS BY A THIRD PARTY (NON-MIZUHO OSI) ESTABLISHMENT. THERE IS ALSO NO EVIDENCE THAT INDICATES THE FREQUENCY OF MAINTENANCE BY THE USER. THE ROOT CAUSE FOR THIS INCIDENT IS THUS DEEMED AS LACK OF PREVENTIVE MAINTENANCE BY THE USER.
PATIENT WAS ON OR BED, AND BED UNEXPECTEDLY MOVED, LEFT SIDE TILTED DOWN. STAFF WAS ABLE TO PREVENT THE PATIENT FROM FALLING, NO HARM TO PATIENT.
PATIENT WAS ON OR BED, AND BED UNEXPECTEDLY MOVED, LEFT SIDE TILTED DOWN. STAFF WAS ABLE TO PREVENT THE PATIENT FROM FALLING, NO HARM TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1673866 | ADVANCED CONTROL I-BASE, DC | OPERATING TABLE | JEA | MIZUHO ORTHOPEDIC SYSTEMS, INC. | 5803 | 00842430106026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |