MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-08-03 for SYSTEM 2000 AR32312-US manufactured by Arjohuntleigh Polska Sp. Zo.o..
[18723126]
It was initially reported by company representative that after completing a bath the psw went to lower the tub. After raising the resident out of the water, the psw reported the tub was at an abnormal angle then a loud bang and water spilling out. No injury reported to either resident or psw.
Patient Sequence No: 1, Text Type: D, B5
[19073378]
(b)(4). This appears to be a "malfunction" type of event not because there was a technical malfunction of the device, but since due to use error the device did not performed as intended. 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 2000 baths to date. With the amount of sold devices and to the comparison of a daily use, we find the occurrence rate for these kinds of events in last 5 years to be very low. The device was inspected by an arjohuntleigh representative at the customer site and found to be to the specification - no fault was found that could cause this failure. The device was being used for pt handling and in that way contributed to the event. From received info no injury occurred to the pt as a result of this incident. Product instruction for use (ifu) is attached with each device. Ifu (operating and daily maintenance instructions 04. Ar. 07/3 gb from february 2003) 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". Device examination performed by a service technician showed that there was no failure that could contribute to this incident-device was working in accordance to its specification. Function test showed that "the only way to duplicate the incident was to put the lift away from the tub legs and have the remote on the outside of the handle facing towards the tub shell. When lowering the tub it was possible to stop one side and then when the blockage couldn't hold the shell anymore the tub would jump and slam". An equilibrium calculation has been establish on system 2000 tubs on the three models 20, 23 and 25, was performed to investigate the risk of the tub tipping over. The criteria was that a person weighing (b)(6) 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 were made to verify the strain that the tub exerts on the floor. From this we can conclude that it is not likely that tub legs could raise by themselves during normal use of the product. Additionally, the received info showed that the customer was using arjo's alenti hygienic chair during the reported incident. The compatibility fo alenti and system 2000 was tested and documented in design verification report. Please note also the ifu for alenti (operating and product care instructions 04. 00. 02/7 us, ca from april 2004) warns: "make sure the alenti is completely clear of all other devices, baths and furniture when being raised or lowered. Make sure the alenti is at least a foot away from the bath tub if the tub is being raised for any reason such as quicker drainage! " and "always remove residents from the bath by completely lowering the tub and raising the alenti only to the extent necessary to clear the tub. Make sure the alenti is at least a foot away from the bath tub or other devices. Always lower the alenti promptly after removing the resident from the bath". From above findings we conclude that this incident is related to user error -not following warnings included in instruction for use. The received info and our eval as described above are showing that if system 2000's and alenti's warnings were followed in accordance to product labeling, there would be no pt or caregiver at risk.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2015-00146 |
| MDR Report Key | 4973010 |
| Report Source | 06,07 |
| Date Received | 2015-08-03 |
| Date of Report | 2015-07-05 |
| Date of Event | 2015-07-05 |
| Date Facility Aware | 2015-07-05 |
| Date Reported to FDA | 2015-08-03 |
| Date Reported to Mfgr | 2015-08-03 |
| Date Mfgr Received | 2015-07-05 |
| Device Manufacturer Date | 2004-06-01 |
| Date Added to Maude | 2015-08-06 |
| 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 | PAMELA WRIGHT |
| Manufacturer Street | 12625 WETMORE, STE 308 |
| Manufacturer City | SAN ANTONIO TX 78247 |
| Manufacturer Country | US |
| Manufacturer Postal | 78247 |
| Manufacturer Phone | 2102787040 |
| 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 | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSTEM 2000 |
| Product Code | ILM |
| Date Received | 2015-08-03 |
| Model Number | AR32312-US |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | 11 YR |
| 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 | 1. Other | 2015-08-03 |