MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-23 for POWERED CHAIR/TRANSPORT CHAIR 54PFS04-TS7 54P SERIES RECLINER manufactured by Champion Manufacturing.
[142811722]
Repair history at this facility was reviewed. No repairs to any chairs for anything related to foot trays were found.
Patient Sequence No: 0, Text Type: N, H10
[142811723]
On 3/26/19 phone call from facility to get written permission to remove foot trays from their chairs, due to several near falls (over the time they have had their chairs) where nurses had to catch patients. The patients think they are standing on the ground, but are standing on the foot tray, when they take a step the stumble or fall. At the time of this phone call, the facility was made aware of the optional yellow foot tray with caution label stating: stow when not in use. Use with staff assistance only. Nurse at the facility provided details of the incident. Patient finished treatment, stood up on foot tray and was waving to someone out the window. She took a step and fell to the floor, fracturing her trochanter head (which the nurse noted was the top of the femur that connects into the hip joint). This required surgery. The nurse also noted that since then the patient has passed, due to the disease process, not the fall.
Patient Sequence No: 0, Text Type: D, B5
| Report Number | 1834066-2019-00001 |
| MDR Report Key | 8540630 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-23 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-02-11 |
| Date Mfgr Received | 2019-03-26 |
| Device Manufacturer Date | 2015-02-26 |
| Date Added to Maude | 2019-04-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERED CHAIR/TRANSPORT CHAIR |
| Generic Name | CHAIR, SURGICAL AC-POWERED |
| Product Code | GBB |
| Date Received | 2019-04-23 |
| Model Number | 54PFS04-TS7 |
| Catalog Number | 54P SERIES RECLINER |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| 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 |
|---|---|---|---|
| 0 | 0 | 1. Required No Informationntervention | 2019-04-23 |