MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-01-22 for SHUTTLE B SERIES 31060001 manufactured by Raye's Inc. (d/b/a Sunflower Medical L.l.c.).
[97887070]
A review of pre-placement inspection records found that the device was found to be in good condition prior to delivery to customer. A review of service tickets found that the customer confirmed the device was delivered in good working condition and that at the time of delivery, the customer declined an inservice on operation of the device. Inspection of the device after the incident found it to be a good working condition. Attempts to duplicate the reported issue were unsuccessful. On 01/09/2018, the customer provided sizewise information on the nature of the injury. The customer reported the device operator sustained a hyper-extended right wrist, which was placed in a brace and required physical therapy. As this injury occurred while the nurse was attempting to operate the device, the device can be said to have contributed to the injury despite not being found to be performing out of specification. As such, this complaint is reportable.
Patient Sequence No: 1, Text Type: N, H10
[97887091]
Customer reports a nurse was reversing the chair back into the corner, and when she released it the chair continued to reverse and "jumped back". Nurse reported injuring her right wrist. On 01/09/2018, customer provided information on the nature of the injury; which was a hyper-extended wrist which required physical therapy and a wrist brace.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001931307-2018-00002 |
| MDR Report Key | 7209563 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-22 |
| Date of Report | 2018-01-18 |
| Date of Event | 2017-11-20 |
| Date Facility Aware | 2017-11-20 |
| Date Mfgr Received | 2018-01-18 |
| Device Manufacturer Date | 2009-06-01 |
| Date Added to Maude | 2018-01-22 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NICHOLAS ROSE |
| Manufacturer Street | 500 COMMERCE PKWY |
| Manufacturer City | HAYS KS 67601 |
| Manufacturer Country | US |
| Manufacturer Postal | 67601 |
| Manufacturer Phone | 8168415391 |
| Manufacturer G1 | RAYE'S INC. (D/B/A SUNFLOWER MEDICAL L.L.C.) |
| Manufacturer Street | 206 JEFFERSON ST. |
| Manufacturer City | ELLIS KS 67637 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 67637 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHUTTLE B SERIES |
| Generic Name | MANUAL PATIENT TRANSFER DEVICE |
| Product Code | FMR |
| Date Received | 2018-01-22 |
| Model Number | 31060001 |
| Lot Number | 54457 |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RAYE'S INC. (D/B/A SUNFLOWER MEDICAL L.L.C.) |
| Manufacturer Address | 206 JEFFERSON ST. ELLIS KS 67637 US 67637 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-22 |