FDA Adverse Event
Malfunction
Summary report: N
PRIDE MOBILITY PRODUCTS
MDR report key: 3891408
·
Received June 24, 2014
Report
- Report Number
- 2530130-2014-00047
- Event Type
- Malfunction
- Date Received
- June 24, 2014
- Date of Event
- June 15, 2014
- Report Date
- September 29, 2014
- Manufacturer
- PRIDE MOBILITY PRODUCTS
- Product Code
- INO
- PMA / PMN Number
- K070950
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE TECHNICIAN EVALUATED AND REPAIRED THE DEVICE. INSTALLED NEW TRANSFORMER AND CABLE.
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR EVALUATION AT THIS TIME. SHOULD FURTHER INFORMATION OR THE DEVICE BECOME AVAILABLE, A FOLLOW-UP REPORT WILL THEN BE ISSUED.
Description of Event or Problem · 1
CUSTOMER ALLEGES HE WAS LIFTING IN THE LIFT CHAIR WHEN IT STOPPED HALFWAY UP AND LOST POWER. CUSTOMER SLID TO FLOOR BUT WASN'T INJURED; 911 CALLED TO HELP CUSTOMER FROM FLOOR.
Description of Event or Problem · 1
CUSTOMER ALLEGES HE WAS LIFTING IN THE LIFT CHAIR WHEN IT STOPPED HALFWAY UP AND LOST POWER. CUSTOMER SLID TO FLOOR BUT WASN'T INJURED. 911 CALLED TO HELP CUSTOMER FROM FLOOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 367747 | PRIDE MOBILITY PRODUCTS | ELECTRIC POSITIONING CHAIR | INO | PRIDE MOBILITY PRODUCTS | LC105 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |