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 2017-02-23 for SLING, CLIP MAA4031-XL manufactured by Arjohuntleigh Polska Sp. Z O.o..
[68088795]
(b)(4). Additional information will be provided upon conclusion of the manufacturer's investigation.
Patient Sequence No: 1, Text Type: N, H10
[68088796]
Arjohuntleigh received customer complaint where it was reported that while the resident was being hoisted off the floor, the right top sling clip broke causing patient to fall. Fortunately, two caregivers were with the resident during the incident and no injury occurred.
Patient Sequence No: 1, Text Type: D, B5
[73360939]
An investigation was carried out into this complaint. Arjohuntleigh was informed about a customer complaint where it was indicated that during the patient's transfer from the floor, the right shoulder clip of the sling broke causing the patient to fall. Two caregivers, who were assisting the resident, prevented the patient from any injury. When reviewing similar reportable events, we have found cases with similar fault description (clip broken). The occurrence rate observed for reportable complaints with this failure mode is currently considered to be low and stable. Arjohuntleigh representative who performed an on-site inspection found the sling fitted with "grey" clips and one of the clips was broken in two pieces. We can state that production of this type of slings was seized around year 2006. The instruction for use's (ifu) that was delivered together with the sling states the sling should be discarded after two years lifetime, or before that, when damaged. Therefore this sling was significantly past its lifetime, it should have been discarded and should not have been used, for many years. Within the scope of a manufacturer investigation, we could stop here, as this device clearly was used far beyond its intended and labelled lifetime. However as shown below we have found that : - despite the device having been used years passed its lifetime, 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 top and bottom of the clip are pushed on. The sling instructions for use contains the crucial information: the useful life expectancy of the arjohuntleigh sling is approximately two years, mechanical pressure - pressing or rolling, during the washing or drying procedures is not allowed. 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. Note that the customer was interviewed by a local arjohuntleigh representative who has reviewed all slings at the facility and recommended to replace another 11 slings due to their condition and age. We find this complaint to be reportable to the competent authorities in abundance of caution, due to reported patient's fall that could lead to serious injury upon reoccurrence. It has been established that the sling was out of manufacturer's specification; it was being used for patient handling at the time of the event and as a result of a use error contributed to the malfunction and the outcome of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2017-00039 |
| MDR Report Key | 6352220 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-02-23 |
| Date of Report | 2017-03-23 |
| Date of Event | 2017-01-31 |
| Date Facility Aware | 2017-02-02 |
| Report Date | 2017-03-23 |
| Date Reported to FDA | 2017-03-23 |
| Date Reported to Mfgr | 2017-03-23 |
| Date Mfgr Received | 2017-02-02 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2017-02-23 |
| 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 | 98282467 |
| Manufacturer G1 | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Street | UL. KS. PIOTRA WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal Code | 62-052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SLING, CLIP |
| Generic Name | AID, TRANSFER |
| Product Code | IKX |
| Date Received | 2017-02-23 |
| Model Number | MAA4031-XL |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH POLSKA SP. Z O.O. |
| Manufacturer Address | UL. KS. PIOTRA WAWRZYNIAKA 2 KOMORNIKI, 62-052 PL 62-052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-23 |