MAUDE Adverse Event Report: CHAMPION MANUFACTURING INC MECHANICAL CHAIR/TRANSPORT CHAIR; MEDICAL RECLINER, PRODUCT CODE: KMN

Model Number 858AV118-TS7JCL

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem Fall (1848)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: MECHANICAL CHAIR/TRANSPORT CHAIR
• Type of Device: MEDICAL RECLINER, PRODUCT CODE: KMN
• Manufacturer (Section D): CHAMPION MANUFACTURING INC; 2601 industrial parkway; elkhart IN 46516
• Manufacturer (Section G): CHAMPION MANUFACTURING INC; 2601 industrial parkway; elkhart IN 46516
• Manufacturer Contact: christine miller ; 2601 industrial parkway; elkhart, IN 46516 ; 8009985018
• MDR Report Key: 7722750
• MDR Text Key: 115413009
• Report Number: 1834066-2018-00004
• Device Sequence Number: 1
• Product Code: KMN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA - CLASS I
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 858AV118-TS7JCL
• Device Catalogue Number: 85 SERIES RECLINER
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/28/2018
• Initial Date FDA Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 128