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 2016-05-25 for SARA STEDY NTB2000 manufactured by Arjohuntleigh Magog Inc..
[45880205]
(b)(4). Additional information will be provided upon conclusion of the manufacturer's investigation.
Patient Sequence No: 1, Text Type: N, H10
[45880206]
Arjohuntleigh has received complaint where it was reported that during transfer to the toilet, the nurse told the resident to take step back from the sara stedy. The resident's leg buckled under the device and she fell. There was no indication of the product malfunction. The resident could not use toilet directly; due to the bathroom design one of the halves could not be raised.
Patient Sequence No: 1, Text Type: D, B5
[53570439]
(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. After review of the reportable complaints for sara stedy, only a limited number of cases were found when the patient fell out of device without any apparent or reported malfunction of the device. The device has been verified and validated for use, and has been with a broad customer base and has seen a great number of uses over the past years. Comparing to the total number of devices sold, the complaint ratio is considered to be very low. No device malfunction was claimed by the customer but the device was not evaluated by arjohuntleigh representative; therefore it is unknown if it was up to manufacturer's specification at the moment of the incident. Note that typically we request the customer to have the device inspected by our technician however despite our best efforts, that was not possible here. We have also not been able to find any contributing manufacturing anomalies. It was reported that the design of the bathroom did not allow approaching the toilet with the device from the front. The issue was detected before and addressed to relevant people: arjohuntleigh representative and facility physiotherapist. The decision was that having the resident take a step backwards off of the sara stedy was not a safe option, but rather having her lower to the toilet at an angle directly from the device would be more appropriate. Apparently, this decision was not well communicated to all staff members in the unit and the event happened when one of the nurses was told to have the patient take a step backwards off of the device. Unfortunately, the resident's leg buckled under the device and she fell between the toilet and the sara stedy. The instruction for use (ifu) which was delivered with the device gives clear guidelines supported with the pictures how to transfer the resident. It also points out that the caregiver must be trained with these instructions and qualified to work with the patient to be transferred. Basing on the information we were able to obtain and evaluate, this incident was most likely caused by a human error as a result of not following the handling procedures described in the ifu. When the ifu would have been followed, it is highly probable that this event would not have happened. The sara stedy was used for the patient care at the time of the event and in that way contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681684-2016-00022 |
| MDR Report Key | 5678266 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-05-25 |
| Date of Report | 2016-04-25 |
| Date Facility Aware | 2016-04-25 |
| Report Date | 2016-08-22 |
| Date Reported to FDA | 2016-08-22 |
| Date Reported to Mfgr | 2016-08-22 |
| Date Mfgr Received | 2016-04-25 |
| Device Manufacturer Date | 2015-06-18 |
| Date Added to Maude | 2016-05-25 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SARA STEDY |
| Generic Name | INM |
| Product Code | INM |
| Date Received | 2016-05-25 |
| Model Number | NTB2000 |
| Operator | NURSE |
| Device Availability | * |
| Device Age | 1 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 | 2016-05-25 |