N
Patient 1
THE DEVICE IS ALMOST 20 YEARS OLD, LONG PAST THE DESIGN LIFE OF 5 YEARS. WE ARE WAITING FOR THE RETURN OF THE DEVICE TO CONDUCT FURTHER EVALUATION.
MAUDE MDR 5994690
- MDR report key
- 5994690
- Report number
- 1319061-2016-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-09-06
- Date received
- 2016-10-03
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 111
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. TRAVIS SCOTT
- Address
- 2032 RT 213 RIFTON NY 12471 US
- Phone
- 845-845-8456
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SMALL MOBILE STANDER | MOBILE STANDER | RIFTON EQUIPMENT | KNL | K13 | K13 | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-10-03 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE CLIENT WAS USING THE STANDER WHEN A STRUCTURAL COMPONENT OF THE STANDER FAILED, ALLOWING THE BODY SUPPORT TO SEPARATE FROM THE FRAME OF THE STANDER. THE CLIENT REPORTEDLY FELL BACKWARDS AND HIT HIS HEAD, BUT WAS NOT INJURED.
N
Patient 1
THE CENTER PANEL HAD CRACKED, CAUSING THE BODY SUPPORT TO SEPARATE FROM THE FRAME. IT IS LIKELY THAT THE CRACKS WOULD HAVE BEEN VISIBLE BEFORE THE FAILURE OCCURED. THE PRODUCT MANUAL SAYS: "INSPECT THIS PRODUCT AND ACCESSORIES REGULARLY FOR LOOSE OR MISSING SCREWS, METAL FATIGUE, CRACKS, BROKEN WELDS, MISSING ATTACHMENTS, GENERAL INSTABILITY OR OTHER SIGNS OF EXCESSIVE WEAR. IMMEDIATELY REMOVE THIS PRODUCT FROM USE WHEN ANY CONDITION DEVELOPS THAT MIGHT MAKE OPERATION UNSAFE."