MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-06-03 for SARA STEDY NTB2000 manufactured by Arjohuntleigh Magog Inc..
[46496237]
(b)(4). This appears to be a "malfunction" type of event not because there was a technical malfunction of the device, but since due to a use error the device did not perform as intended. An investigation was carried out into this complaint. Arjohuntleigh has received a customer complaint where it was reported that a resident was being transferred from sara stedy mobile active lift to the recliner. The sara stedy was unable to get close enough to the chair and when the resident was taking a step back, she stumbled while trying to sit in the recliner. The caregiver caught the patient and received a minor injury. After review of reportable complaints for sara stedy and stedy (which has very similar construction), descriptions of (b)(4) of them suggest relation to events where the patient fell or almost fell, where no malfunction of the device was found. Please note that arjohuntleigh manufactured about (b)(4) stedy and (b)(4) sara stedy to date. Compared to the amount of sold devices and in comparison to their daily use, amount of reportable complaints with this failure mode is considered to be very low. From the gathered information, and also confirmed by the customer, it can be read that sara stedy could not be operated according to the instruction for use, which was delivered with the device, due to the construction of the recliner that was used. This recliner was too wide and sitting too low over the floor to enable entering sara stedy's legs underneath; therefore the resident had to take a step back to sit on the recliner. This way of handling is not consistent with the ifu, which clearly states how this type of transfer should be carried out. From the received information and our evaluation as presented above and confirmed by the user facility, user error cannot be ruled out as carrying the transfer of the resident not according to the instruction for use due to recliner construction most likely contributed to the reported event. If sara stedy's handling procedures were followed in accordance to instruction for use, there would be no patient or caregiver at risk. We find this complaint to be reportable to the competent authorities in abundance of caution, because the fall was reported. There was no indication of product malfunction. It was being used for patient handling and likely due to use error contributed to the outcome of the event.
Patient Sequence No: 1, Text Type: N, H10
[46496238]
Arjohuntleigh has received a customer complaint where it was reported that a resident was being transferred from sara stedy mobile active lift to the recliner. The sara stedy was unable to get close enough to the chair and when the resident was taking a step back, stumbled while trying to sit in the recliner. The caregiver caught the patient and received a minor injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681684-2016-00026 |
| MDR Report Key | 5697088 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-06-03 |
| Date of Report | 2016-05-06 |
| Date of Event | 2016-05-05 |
| Date Facility Aware | 2016-05-06 |
| Report Date | 2016-06-03 |
| Date Reported to FDA | 2016-06-03 |
| Date Reported to Mfgr | 2016-06-03 |
| Date Mfgr Received | 2016-05-06 |
| Device Manufacturer Date | 2013-06-06 |
| Date Added to Maude | 2016-06-03 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. PAMELA WRIGHT |
| Manufacturer Street | 12625 WETMORE, STE 308 |
| Manufacturer City | SAN ANTONIO TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal | 78247 |
| Manufacturer Phone | 2103170412 |
| Manufacturer G1 | ARJOHUNTLEIGH MAGOG INC. |
| Manufacturer Street | 2001, TANGUAY |
| Manufacturer City | MAGOG, QC J1X 5Y5 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | J1X 5Y5 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SARA STEDY |
| Generic Name | INM |
| Product Code | INM |
| Date Received | 2016-06-03 |
| Model Number | NTB2000 |
| Device Availability | * |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH MAGOG INC. |
| Manufacturer Address | 2001, TANGUAY MAGOG, QC J1X 5Y5 CA J1X 5Y5 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-06-03 |