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 2015-08-11 for SARA 3000 HEA0002 manufactured by Arjohuntleigh Polska Sp. Zo.o..
[23154891]
(b)(4). Additional information will be provided upon conclusion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[23154892]
It was reported by the customer representative that before a transfer with the sara 3000 standing aid, a resident set on the edge of the bed, put his feet on the foot support of the lifter and caregiver tried to attach the leg support strap to secure the legs of the patient. Suddenly the resident removed his leg from the lifter and twisted it.
Patient Sequence No: 1, Text Type: D, B5
[40310925]
(b)(4). It was reported to arjohuntleigh some time after the event that while a caregiver was attending to secure the resident's leg on the sara 3000 foot plate platform, a patient's feet slipped off the foot plate support. The event outcome was indicated to be a fracture of the left leg and as a consequence the patient required hospitalization. When reviewing similar reportable events for sara 3000 devices, we have found a number of cases related to this type of event: a patient not suited for use with the device. The occurrence rate of a reportable complaint with this event description is relatively low. When the event occurred, the device was used for treatment of a person, it played a role in the event. After the event, the device was put through a function test and no deviation was observed - the device was in full working order. From this it appears the device was up to specification at the time of the incident. In accordance to the information provided, the resident's leg slipped off the foot plate platform while she was sitting on the bed. It means that at the time of incident the resident was not bearing her weight. There was also no slipping of her body out of the supporting sling reported. Please note that as per sara 3000 device design, the foot plate platform is inserted a few centimeters above the floor, parallel to it. Therefore, to slip the feet from the foot plate surface, the patient would need to have removed her feet on her own accord. The outcome of the issue, indicated as a leg fracture would also indicate that the leg movement was unexpected. Based on our best product knowledge it was concluded to be very unlikely that the patient will have fractures from the lifting system even if the patient's feet slip off the foot plate support. Therefore the most common and likely root cause for this event is that the patient could have additional health issues prior to the lift usage which could lead to the fractures in easy way - eg. Severe osteoporosis. Based on the above, our findings appears to point to the facility staff not knowing or otherwise understanding of the necessity of the professional assessment of the patient before transfer as indicated in the instruction for use (ifu), which in turn makes it unlikely the professional judgment of the patient was followed. Our evaluation appears to be in line with an use error having occurred: our assumption is that the facility staff does not understand the importance of the patient assessment which should be carried out by a qualified nurse or therapist before lifting process. In the labelling there is a particular attention to the responsibility of the device owner to make sure that the device users are trained and knowledgeable of the contents of the labelling. When the ifu would have been followed and the professional assessment of the patient before transfer would be provided before transfer, the event would have been avoided. From this evaluation it would appear most likely that the event was caused by the user not following the ifu, due to lack of awareness of the ifu contents. We find this complaint to be reportable to the competent authorities.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2015-00153 |
| MDR Report Key | 5003236 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2015-08-11 |
| Date of Report | 2015-08-26 |
| Date of Event | 2015-01-04 |
| Date Facility Aware | 2015-07-21 |
| Report Date | 2015-08-11 |
| Date Reported to FDA | 2015-08-11 |
| Date Reported to Mfgr | 2015-08-11 |
| Date Mfgr Received | 2015-07-21 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2015-08-14 |
| 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 STE 308 |
| Manufacturer City | SAN ANTONIO TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal | 78247 |
| Manufacturer Phone | 2103170412 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP. ZO.O. |
| Manufacturer Street | UL. KS. PIOTRA WAWRZYNIAKA 2 |
| Manufacturer City | KOMOMIKI PL-62052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | PL-62052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SARA 3000 |
| Generic Name | SARA 3000 |
| Product Code | FNG |
| Date Received | 2015-08-11 |
| Model Number | HEA0002 |
| Device Availability | Y |
| Device Age | 5 NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. ZO.O. |
| Manufacturer Address | UL. KS. PIOTRA WAWRZYNIAKA 2 KOMORNIKI PL-62052 PL PL-62052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-08-11 |