MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-05-22 for MECHANICAL CHAIR/TRANSPORT CHAIR 547FL06-TS 54 SERIES RECLINER manufactured by Champion Manufacturing.
[108905360]
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.
Patient Sequence No: 1, Text Type: N, H10
[108905361]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1834066-2018-00001 |
| MDR Report Key | 7533699 |
| Report Source | OTHER |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-10 |
| Date of Event | 2017-02-18 |
| Date Mfgr Received | 2018-04-10 |
| Device Manufacturer Date | 2004-12-01 |
| Date Added to Maude | 2018-05-22 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 G1 | CHAMPION MANUFACTURING |
| 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 | MECICAL RECLINER |
| Product Code | KMN |
| Date Received | 2018-05-22 |
| Model Number | 547FL06-TS |
| Catalog Number | 54 SERIES RECLINER |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHAMPION MANUFACTURING |
| Manufacturer Address | 2601 INDUSTRIAL PARKWAY ELKHART IN 46516 US 46516 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-22 |