MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2013-07-05 for SARA PLUS manufactured by Arjohuntleigh Polska Sp. Zo.o..
[3652746]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10968261]
This report is being filed under (b)(4) by arjohuntleigh (b)(4). On behalf of the importer (b)(4). When reviewing similar reportable events, we found some cases with similar fault description (slipping out of the sling or from the footplate resulting in fall/injuries), which were found to mainly related to use error. The trend observed for reportable complaints with this failure mode on sara plus is considered to be low and stable. We were not able to find a deficiency with the device. This means that the lifting system was up to specification when the event took place. The device was being used for patient handling and in that way contributed to the event. As part of the information received for this event, we were informed of that the sling chest strap that is meant as a helping feature to hold the sling in place on the body, was indicated to have become damaged at its fixations. From our investigation, we have come to find that this damage was a consequence of and not cause for-the event. In other words, it appears the sling was up to specification at the time of the event. From our evaluation, it appears a number-of use errors caused the event. The most relevant use error being a failure to properly use lift cord ropes: it is stated in the instruction for use (kkx52180m-en issue 2): important: always check that the sling adjustment cords are fully in position and locked before and during the commencement of the lifting cycle, and in tension as the patients' weight is gradually taken up. " 'when the patient is seated in the new position, and you wish to remove the sling. Pull each cord up from the locking cleats and slacken the cords sufficiently to release the loop lock fitting, then remove the cords from the sling. ' we have not been able to find any contributing manufacturing anomalies. The root cause of the complaint was found to be an use error since the received information and our evaluation as described above are showing that if the safety warnings present in the instructions for use to correctly use the device are followed, it appears very unlikely that there will be any patient or caregiver risk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2013-00035 |
| MDR Report Key | 3226016 |
| Report Source | 05,06,07 |
| Date Received | 2013-07-05 |
| Date Mfgr Received | 2013-06-07 |
| Date Added to Maude | 2013-07-16 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVE KAHN |
| Manufacturer Street | 2349 WEST LAKE ST. |
| Manufacturer City | ADDISON IL 60101 |
| Manufacturer Country | US |
| Manufacturer Postal | 60101 |
| Manufacturer Phone | 8003231245 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP. ZO.O. |
| Manufacturer Street | UL. KS. WAWRZYNIAKA 2 KOMORNIKI |
| Manufacturer City | POZNAN 62052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62052 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SARA PLUS |
| Generic Name | NONE |
| Product Code | FRW |
| Date Received | 2013-07-05 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. ZO.O. |
| Manufacturer Address | UL. KS. WAWRZYNIAKA 2 KOMORNIKI POZNAN 62052 PL 62052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-05 |