MAUDE Adverse Event Report: CHAMPION MANUFACTURING MECHANICAL CHAIR/TRANSPORT CHAIR; MECICAL RECLINER

Model Number 547FL06-TS

Device Problem Device Handling Problem (3265)

Patient Problem Laceration(s) (1946)

Event Date 02/18/2017

Event Type  Injury  

Manufacturer Narrative

Review of operator manual that accompanied the chair page 7 states proper in-service procedures.Pages 16 and 17 contain a caution that states: caution: this chair has moving parts that may create pinch points.Work carefully.Have your hands clear of the mechanism when you move the chair from one position to another.In addition to the initial shipment of chairs, there were four additional shipments of similar chairs received at this facility since this specific chair was purchased.All had operator manuals noting the proper operation of the recliners, including directions for staff to safely assist a patient in positioning the chair if they need assistance.The manual also contains cautions about keeping your hands clear of the mechanism.The in-service packet also comes with a video showing safe operation of the chair by a patient and by staff assisting the patient.Review of service parts and sales activity at this particular clinic shows no significant repair to the mechanical parts of their chairs.Routine follow up call noted chairs operating properly and there were no questions or concerns from staff.On 11 april 2018, champion verified with the facility that they no longer had serial (b)(4).The facility representative said he thought they discarded the chair when they purchased all new chairs from champion.

Event Description

A technician was assisting a patient onto a recliner.The actuator handle was pulled to release the footrest and the technician's hand was in the path of the opening footrest.The technician pinched his left ring finger in the mechanism of the chair, resulting in a skin trauma of laceration 2 cm square in size.

• Brand Name: MECHANICAL CHAIR/TRANSPORT CHAIR
• Type of Device: MECICAL RECLINER
• Manufacturer (Section D): CHAMPION MANUFACTURING; 2601 industrial parkway; elkhart IN 46516
• Manufacturer (Section G): CHAMPION MANUFACTURING; 2601 industrial parkway; elkhart IN 46516
• Manufacturer Contact: christine miller ; 2601 industrial parkway; elkhart, IN 46516
• MDR Report Key: 7533699
• MDR Text Key: 108905360
• Report Number: 1834066-2018-00001
• Device Sequence Number: 1
• Product Code: KMN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Technologist
• Device Model Number: 547FL06-TS
• Device Catalogue Number: 54 SERIES RECLINER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 75