MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-12-14 for SYSTEM 2000 AAR31202-CA manufactured by Arjohuntleigh Polska Sp Z O.o.
[62540372]
(b)(4). Please note that previous medwatch reports for this product may have been submitted for the manufacturing site (b)(4). As of 2014 that number was de-activated due to the site no longer shipping product to the usa. From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under (b)(4). Additional information will be provided upon the investigation completion.
Patient Sequence No: 1, Text Type: N, H10
[62540373]
Arjohuntleigh has received a customer complaint where it was indicated that the tub had tipped over, not right over but up against the wall. The resident was not in the tub at the time, but in the sling. The caregiver and resident were not injured. This issue was not reported to the staff or nursing manager and the maintenance person was unfamiliar with the care aid so the facility has no report or indication that this event occurred. The preventive maintenance was successfully performed with no outstanding issues and could not find any witness marks that would indicate a problem with the tub. The tub functioned normally, the legs were torqued as per specification, tub shell was torqued. The feet of the tub were straight and appeared in good working order. The tub cannot be tipped by pushing on it or by jamming an object below it.
Patient Sequence No: 1, Text Type: D, B5
[65929331]
(b)(4). Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjo hospital equipment (b)(4) (under registration #(b)(4)). As of 2014 that number was de-activated due to the site no longer shipping product to the usa. From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4) complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4). An investigation was carried out into this complaint. When reviewing similar reportable events for system 2000 we have found a very low number of other similar cases - tub was tipping during use due to misuse. Arjohuntleigh manufactured over (b)(4) system (b)(4) baths to date. With the amount of sold devices and to the comparison of a daily use, we find the occurrence rate for this kind of events in last 5 years to be very low and stable. Product instruction for use (ifu) is provided with each device. Ifu (operating and daily maintenance instructions 04. Ar 08/2 gb from march 2000) warns: "when lowering the bath tub the operator must ensure that there are no obstructions in the immediate vicinity that could impede its downward movement. Failure to remove obstructions could result in severe injury to operator/resident and damage the tub. When raising the bath, ensure that no part of the resident lift chair or stretcher is in contact with the bottom or rim of the tub. Do not allow the resident or operator to sit on the end or side of the bath tub. " additionally, the equilibrium calculation has been established on system 2000 tubs and included in test report (b)(4) dated on 2007-apr-04. An equilibrium calculation on the three models: 20, 23 and 25 was made to investigate the risk of the tub tipping over. The criteria was that a person weighing 182 kg should be able to stand in a tub filled with water at the position where the back slope begins without any risk for the tub to tip over. The calculations show that all the models reach the set criteria. Calculations are made to verify the strain that the tub expose on the floor. From this we can conclude that it is not likely that tub legs could rise by itself during normal use of the product. From above evaluation and similar complaints received to date, it is very likely that the tub was lowered onto lift's actuator and was either lowered further by the caregiver or the lift was raised causing tipping of the bath and its dislocation. Despite the technician's efforts, it was impossible to reach the witness of the incident, therefore there is no information about the exact incident description. It is known that the lift used at the moment of incident was alenti and during the visit at the customer the technician witnessed its bent arm - however there is no confirmation that this damage was caused by investigated incident. From above findings we conclude that this incident was most likely related to use error - not following warnings included in the instruction for use. The received information and our evaluation as described above are showing that if system 2000's warnings were followed in accordance to product labeling, there would be no patient or caregiver at risk. The device was inspected by an arjohuntleigh representative at the customer site and found to be up to the specification - no fault was found that could cause or contribute to the reported incident. The device was being used for patient handling and in that way contributed to the incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2016-00253 |
| MDR Report Key | 6173066 |
| Report Source | USER FACILITY |
| Date Received | 2016-12-14 |
| Date of Report | 2016-11-23 |
| Date Facility Aware | 2016-11-23 |
| Report Date | 2017-01-13 |
| Date Reported to FDA | 2017-01-13 |
| Date Reported to Mfgr | 2017-01-13 |
| Date Mfgr Received | 2016-11-23 |
| Device Manufacturer Date | 2006-04-03 |
| Date Added to Maude | 2016-12-14 |
| 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. KINGA STOLINSKA |
| Manufacturer Street | KS. WAWRZYNIAKA 2 |
| Manufacturer City | KOMORNIKI, TX 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer Phone | 2103170412 |
| 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 | SYSTEM 2000 |
| Generic Name | HYDRO-MASSAGE BATH, INSTITUTIONAL |
| Product Code | ILM |
| Date Received | 2016-12-14 |
| Model Number | AAR31202-CA |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 128 MO |
| 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 | 2016-12-14 |