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 858AV118-TS7JCL 85 SERIES RECLINER manufactured by Champion Manufacturing Inc.
[115413009]
This is the only complaint out of approximately (b)(4) chairs built over the last (b)(4) years. Patient exceeded the weight limit for the foot tray and proceeded to step on it. No mention of staff being in attendance as patient was entering the chair. Operator manual page 14 contains instructions for proper use of foot tray and warnings. Proper use of foot tray the foot tray is a feature available on many champion recliner models. The foot tray is useful as an assist for patients getting into or out of the recliner, re-positioning in the recliner, and as a foot support while sitting fully upright or being transported in the recliner. Warning: never move chair while patient is in the seat in the upright position with their feet dangling. Warning: the foot tray can support up to 225 lbs, but may become "tippy" with weights over that. The foot tray pulls out from under the recliner foot rest. Before use make sure chair casters are locked and ensure that the foot tray is in the fully-extended position. To fully extend the foot tray pull it out from the front of the recliner until you feel the front edge of the foot tray drop slightly. In this position, the foot tray cannot be pushed back under the chair to the "stowed" position unless you first lift on the front edge of the tray. To stow the foot tray, lift up on the front edge of the tray and slide it back under the recliner as far as it will go. Staff should always advise patients that the foot tray has been extended. Staff should never allow a patient to stand on the foot tray unattended. Patients over 225 lbs. Should not use the foot tray as a step. Warning: any recliner not equipped with a foot tray is not considered an appropriate transport chair. Foot tray is also available in yellow and can come with a warning label and clear tread. Manufacturing work instructions and training documents were reviewed and found to be in place and complete. Line remedial action tracking records reviewed for past 3 years tech went into facility and inspected chair, he found the foot tray had come out of its track and the cause was a loose bolt on the front right side of the track. He replaced tracks and foot tray, and all nuts, bolts, and washers on track assemblies. He also inspected all other chairs arrived in that same delivery and verified all parts were tightened and working properly. Facility was expecting more chairs to arrive soon and the tech will return to inspect them.
Patient Sequence No: 1, Text Type: N, H10
[115413030]
Phone call on (b)(6) 2018. Nurse reported on (b)(6) 2018 at 4:30 am a (b)(6) patient stepped onto the foot tray (rated for 225 lbs) to enter the chair. Foot tray became detached from the chair and collapsed. Patient fell. Facility asked if patient was okay, she said yes and did not receive any treatment or intervention. Phone call on (b)(6) 2018 nurse called back at 9am to inform us that the patient had continuing pain and went to the er. Where she was diagnosed with 4 broken toes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1834066-2018-00004 |
| MDR Report Key | 7722750 |
| Report Source | USER FACILITY |
| Date Received | 2018-07-26 |
| Date of Report | 2018-07-24 |
| Date of Event | 2018-06-28 |
| Date Mfgr Received | 2018-06-28 |
| Device Manufacturer Date | 2018-06-05 |
| 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MECHANICAL CHAIR/TRANSPORT CHAIR |
| Generic Name | MEDICAL RECLINER, PRODUCT CODE: KMN |
| Product Code | KMN |
| Date Received | 2018-07-26 |
| Model Number | 858AV118-TS7JCL |
| Catalog Number | 85 SERIES RECLINER |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 |