MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-03-28 for FLUIDAIR ELITE manufactured by Arjohuntleigh, Inc..
[104148387]
Please note that this product is no longer manufactured and previous medwatch reports for this product may have been submitted for the manufacturing site kinetic concept inc (under registration #(b)(4)). From (b)(6) 2012 until 2014 complaints related to this product were handled by arjohuntleigh inc, and any medwatch reports were submitted under registration #(b)(4). From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh ab's complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4). The investigation has been completed and conclusions are following. On 5 january 2018 an arjohuntleigh was notified about 2 incidents with the involvement of fluidair elitetm therapy system indicating that customer staff were injured while patient repositioning. In order to obtain more information to the reported incidents, we have contacted the customer several times. After the attempts, on (b)(6) the customer informed that total of 4 staff injuries sustained. Therefore additional 2 incidents have been recorded (all have been reported separately to competent authority under mdr 3007420694-2018-00021, 3007420694-2018-00022, 3007420694-2018-00072 and 3007420694-2018-00073). The injuries occurred on (b)(6) 2017 as a result of repetitive motions while repositioning patients on the bed wedges over a period of time. The customer reported that "all injuries were beyond first aid and involved back/shoulders injuries", however refused to provide detailed information on the types of injuries. Additionally, only one serial number of the bed was identified by the customer as involved in at least two incidents (this was reported under mdr 3007420694-2018-00021 and 3007420694-2018-00022). There was no allegation indicating technical failure within the bed. The customer stated that the bed design does not allow for proper body mechanics when repositioning onto the wedge. Also that there is no safe patient handling equipment approved by manufacturer for repositioning of post flap spinal cord injury patients. Please note that foam wedges are installed under patient's head, if required, to raise the patient torso. User manual 300510-ah rev. C dated on february 2015 provides the following indications, warnings and precautions: 1. "general protocol - follow all applicable safety rules and institution protocols concerning patient and caregiver safety". Every hospital has their own protocols that dictate how patients are turned for both the safety of a caregiver and patient. Information received from arjo account manager was that the injury occurred potentially due to a positioning technique used during training. 2. "patient repositioning using dri-flo underpad. 1. Lower side rails. 2. Take position on each side of patient (two people will be needed). Roll edges of dri-flo on each side of patient to get a firm grip. To lift and properly position patient in the unit. 3. Note: the retractable side step on each side of the unit may be lowered to facilitate repositioning. 4. Use dri-flo underpad to lift and properly position patient in unit. " taking the above into account, the customer allegation cannot be acknowledged. There was no allegation of product failure that could contribute to the injury but rather user repositioning techniques contributed to the issue. Because four incidents occurred at one facility and it seems that repositioning techniques or incorrect protocol used contributed to the reported issue, a re-training will be scheduled at the customer convenience. Initially, this complaint was assessed as reportable due to information of staff injury. After multiple unsuccessful attempts to gain additional information from the customer on the types of injuries alleged, no information that would suggest any serious injuries was provided by the customer. There was no allegation of product failure, but user techniques used while patient repositioning contributed to the issue. Since the four incidents were reported by one customer, they are considered singular occurrence. No other similar complaints have been found. For this reason, we do not consider this event reportable to competent authorities in the future. The device did not fail to meet its performance specification, it was used for a patients treatment at the time of incidents and therefore played role in the events but was not directly involved with the reported injury.
Patient Sequence No: 1, Text Type: N, H10
[104148388]
It was reported to arjohuntleigh that a caregiver sustained injuries while repositioning patients on fluidair (s). During attempts to obtain more information from the facility to incidents reported under mdr 3007420694-2018-00021 and 3007420694-2018-00022, we were notified that there were 2 other injuries sustained by caregivers. According to the customer "all injuries were beyond first aid and involved back/shoulders injuries".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007420694-2018-00073 |
| MDR Report Key | 7377931 |
| Report Source | USER FACILITY |
| Date Received | 2018-03-28 |
| Date of Report | 2018-03-28 |
| Date of Event | 2017-12-01 |
| Date Mfgr Received | 2018-02-27 |
| Date Added to Maude | 2018-03-28 |
| 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 | UL. KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, 62-052, P |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052, PL |
| Manufacturer G1 | ARJOHUNTLEIGH, INC. |
| Manufacturer Street | 4958 STOUT DRIVE |
| Manufacturer City | SAN ANTONIO TX 78219 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78219 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLUIDAIR ELITE |
| Generic Name | BED, AIR FLUIDIZED |
| Product Code | INX |
| Date Received | 2018-03-28 |
| Operator | OTHER CAREGIVERS |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJOHUNTLEIGH, INC. |
| Manufacturer Address | 4958 STOUT DRIVE SAN ANTONIO TX 78219 US 78219 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-28 |