PRIDE MOBILITY PRODUCTS
Report
- Report Number
- 2530130-2023-00118
- Event Type
- Injury
- Date Received
- August 1, 2023
- Date of Event
- June 26, 2023
- Report Date
- June 26, 2024
- Manufacturer
- PRIDE MOBILITY PRODUCTS
- Product Code
- ITI
- UDI-DI
- 00606509200158
- PMA / PMN Number
- K143383
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
PER CURTIS: CTLDC1540 THE CONTROLLER WAS LOW POWER BENCH TESTED WITH THE 1741 HANDCONTROL THAT CAME WITH IT. THE CONTROLLER PASSED LOW POWER BENCH TESTING. NO ERRACTIC BEHAVIOR AS REPORTED. FAULT HISTORY: JOYSTICK OOC, CURRENT SENSOR FAULT, JOYSTICK OUT OF RANGE, BRAKE ON FAULT, JOYSTICK STUCK OOC, HANDCONTROL EEROM FAULT. AWAITING TO BE TESTED ON THE ATS... UPDATE 11/08/2023: THE CONTROLLER WAS TESTED AND PASSED ATS. THE CONTROLLER WAS NFF. CTLDC1554 THE JOYSITCK KNOB (CPN (B)(4)) WAS MISSING FROM THE HANDCONTROL. THE HANDCONTROL WAS LOW POWER BENCH TESTED WITH THE 1740 CONTROLLER THAT CAME WITH IT. THE HANDCONTROL PASSED LOW POWER BENCH TESTING. NO ERRACTIC BEHAVIOR AS REPORTED. AWAITING TO BE TESTED ON THE ATS...UPDATE 11/08/2023: THE HANDCONTROL WAS TESTED AND PASSED ATS. THE HANDCONTROL WAS NFF.
THE DEVICE HAS NOT YET BEEN MADE AVAILABLE FOR EVALUATION. SHOULD FURTHER INFORMATION OR THE DEVICE BECOME AVAILABLE, A FOLLOW-UP REPORT WILL THEN BE ISSUED.
ALLEGES POWER CHAIR WAS SPINNING FAST AT HIGH VELOCITY CLOCKWISE BEFORE THE CHAIR AND RESIDENT ALLEGEDLY FELL FORWARD.
ALLEGES POWER CHAIR WAS SPINNING FAST AT HIGH VELOCITY CLOCKWISE BEFORE THE CHAIR AND RESIDENT ALLEGEDLY FELL FORWARD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2336091 | PRIDE MOBILITY PRODUCTS | WHEELCHAIR, POWERED | ITI | PRIDE MOBILITY PRODUCTS | Q6 EDGE 3 | N/A | 00606509200158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |