MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-07-26 for MECHANICAL CHAIR/TRANSPORT CHAIR UNKNOWN manufactured by Champion Manufacturing Inc.
[115123206]
Assuming this is a champion chair (which could not be verified), it has been determined this is an operational issue. Review of operator manual provides proper operation of foot tray and warnings on page 14. Review of the history of this facility shows they have purchased over 100 chairs on a periodic basis from champion from 2004 through 2017. Review of service parts and sales activity over that timeframe shows no repairs done to their chairs or mechanical parts purchased that would pertain to any foot trays. Facility ordered (140) sets of 3" casters june 4, 2018.
Patient Sequence No: 1, Text Type: N, H10
[115123207]
On 4/6/2018 phone call from facility was to order replacement parts. The facility wanted to order optional smaller casters. There was no complaint stated, but it was mentioned that the facility decided to remove the foot trays due to patient falls and now the chairs are too high for many patients. Facility was made aware of the optional yellow foot tray and with a caution label in english, french and spanish for higher visibility, they declined that option. Caution label states: caution weight capacity 225 lbs. Stow when not in use. Use with staff assistance only. On 5/31/2018 phone call advised that sometime near the beginning of the year (2018) a patient sitting in a chair, she stood up unattended on the foot tray that was left extended, took a step and fell. The patient fell and fractured her femur, which required surgery to repair. On 6/15/2018 phone call produced the information regarding the individual involved and information that no serial number was recorded for this incident, no date or time of incident was reported. It is assumed this is a champion product but that cannot be verified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1834066-2018-00003 |
| MDR Report Key | 7722751 |
| Report Source | USER FACILITY |
| Date Received | 2018-07-26 |
| Date of Report | 2018-07-24 |
| Date Mfgr Received | 2018-06-15 |
| Date Added to Maude | 2018-07-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTINE MILLER |
| Manufacturer Street | 2601 INDUSTRIAL PARKWAY |
| Manufacturer City | ELKHART IN 46516 |
| Manufacturer Country | US |
| Manufacturer Postal | 46516 |
| Manufacturer Phone | 8009985018 |
| Manufacturer G1 | CHAMPION MANUFACTURING INC |
| Manufacturer Street | 2601 INDUSTRIAL PARKWAY |
| Manufacturer City | ELKHART IN 46516 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46516 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MECHANICAL CHAIR/TRANSPORT CHAIR |
| Generic Name | MEDICAL CHAIR AND TABLE |
| Product Code | KMN |
| Date Received | 2018-07-26 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHAMPION MANUFACTURING INC |
| Manufacturer Address | 2601 INDUSTRIAL PARKWAY ELKHART IN 46516 US 46516 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-26 |