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 2017-04-13 for SLINGS, CLIP MAA4100M-L manufactured by Arjohuntleigh Polska Sp Z O.o.
[72805139]
(b)(4). An investigation was carried out into this complaint. It was reported that one of sling clips being used with maxi sky 600 ceiling lift broke whilst hooking up on the device spreader bar before commencing to the patient transfer. Fortunately, no injuries were sustained by patient or caregiver. When reviewing similar reportable events, we have found cases with similar fault description (clip breakage). The involved sling was inspected by arjohuntleigh representative -the sling label was found to be completely unreadable. Therefore we cannot determine its manufacturing date with a certainty. We were not provided with any pictures of this faulty item either. Unfortunately, it is not possible to determine the sling condition, neither location of the broken clip. It was informed that the customer facility have been trained in terms of replacing slings when their tags are no longer readable. Please note that passive sling clip instruction for use (ifu)includes the following warning: "before every use: (... ) check all parts of the sling. If any part is missing or damaged - do not use the sling. Check for: fraying, loose stitching, tears, fabric holes, soiled fabric, damaged clips, unreadable or damaged label. " this may point to the facility staff not knowing of the necessity of the pre-use checks as indicated in the ifu, which in turn makes it unlikely the pre-use check were followed. From previous investigations into similar problems, it is concluded that the damage to the clip is not likely to have occurred during or due to on-label use. All sling clips outperform their specification, except when damaged. There is the statement on the sling label itself, but also in the corresponding ifu, that the sling is not to be dried with a washing press or similar method. This is because doing so can mean that the clip receives a mechanical pressure much higher and from a different position (outside rather than inside) than it was intended for. It can cause bending, deforming, hairline cracks or even outright breakages of the clip before or during use. Following the ifu - "cleaning: (... ) do not wash with rough surfaces or sharp objects, (... ), use any mechanical pressure, pressing or rolling, (... ) tumble dry, ironing. " despite the sling label was unreadable, this does not appear to be the reason for clip breakage. The clip breakage is found most likely due to further off-label use: not following the washing and drying instructions. Based on the information received regarding the incident and our product knowledge it comes forward that we see clip breakage occur in three general ways: from left to right, from top to bottom and at the lower bar (the weakest part of the clip). A breakage here is what is expected to occur when a clip is pinched with a force much higher than the force it will normally receive during use. This occurs when a clip is bent in e. G. : a washing press, with enormous force, while the left and right sides of the clip are pushed on. 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's contents. Arjohuntleigh suggests additional reminding the staff involved of the device labelling, with special attention to correct washing procedure and proper sling inspection for damages before each patients transfer. This is to be communicated to the customer. Looking at the incident scenario, it is found the device was being used for treatment of the patient when the event occurred and it was directly involved with the reportable incident. It was decided to be reportable to the competent authorities in abundance of due to the fact that such circumstances with patient attached on the sling upon recurrence may result in harm of high severity. The device was not up to its specification at the time of the event - the arjohuntleigh sling clip got broken.
Patient Sequence No: 1, Text Type: N, H10
[72805140]
On (b)(6) 2017 it was reported to arjohuntleigh that one of sling clips being used with maxi sky 600 ceiling lift broke whilst hooking up with resident before transfer. No injuries were sustained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2017-00083 |
| MDR Report Key | 6489999 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-04-13 |
| Date of Report | 2017-04-13 |
| Date of Event | 2017-03-17 |
| Date Facility Aware | 2017-03-20 |
| Report Date | 2017-04-13 |
| Date Reported to FDA | 2017-04-13 |
| Date Reported to Mfgr | 2017-04-13 |
| Date Mfgr Received | 2017-03-20 |
| Date Added to Maude | 2017-04-13 |
| 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 | MS. KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer Phone | 698 282 46 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP Z O.O |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-052 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SLINGS, CLIP |
| Generic Name | DAILY ACTIVITY ASSIST DEVICE |
| Product Code | IKX |
| Date Received | 2017-04-13 |
| Catalog Number | MAA4100M-L |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP Z O.O |
| Manufacturer Address | KS. WAWRZYNIAKA 2 KOMORNIKI, 62-052 PL 62-052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-13 |