MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-12-13 for SYSTEM 2000 AR52101-EU manufactured by Arjo Hospital Equipment Ab.
[62249685]
(b)(4). Additional information will be provided upon the investigation completion.
Patient Sequence No: 1, Text Type: N, H10
[62249686]
Arjohuntleigh received a customer complaint for system 2000 bath. It was reported that when the bathing procedure started, the temperature was set and checked. The resident was transferred to the bath using a lift. The caregiver did not take a look at the display in the meanwhile. After touching the water, the resident said it was far too hot. The caregiver checked the display again and found out that the temperature was raising. The resident was lifted out the bath immediately and placed on the bed.
Patient Sequence No: 1, Text Type: D, B5
[64459289]
(b)(4). An investigation was carried out into this complaint. When reviewing similar reportable events for system 2000 baths we have found one other similar case where the user was scalded due to too hot fill or shower water. There is no complaint trend for this kind of events. System 2000 is a height adjustable bath system intended for assisted bathing. It is equipped with thermostatic mixer that contains 3 temperature and pressure controlled cartridges. The temperature control system is manual in this model, operated with a control knob from the front panel through a gear. There is an adjustable stop ring behind the control knob to set the maximum allowed temperature of the hot water. Instruction for use (ifu) is provided with each device. Ifu (operating and daily maintenance instructions 04. Ar. 10/2 ca from september 2001) provides information about safe and correct use of the product. It informs that user must always make sure that: "the water/shower temperature is checked by hand before the bath". Assisted bathing of the patient is described in resident handling instruction (04. Ar. 11/1gb from september 1999 - excerpt attached) which also points out importance of checking water temperature before use: "check the bath water temperature before the resident enters the water". Please note that device examination showed that the stop ring of the control knob was damaged. The exact cause of this failure is unknown, however there are several possibilities for this failure: - excessive force applied to the control knob when adjusting the temperature to the highest value, - attempts to overturn the knob outside the maximum allowed temperature, - the knob could have been incorrectly maintained as the ifu informs that every month the caregiver must "check that all screws, bolts and other joints are perfectly tight", - weakening of the stop ring due to its age. Due to the age of this bath, it should be considered to have it replaced. Despite fact that there was no obvious sign of damage, the age of the device is significant when this kind of the malfunction is occurring and this factor could have contributed to stop ring breakage. Looking at the date of production of this device, it was manufactured in 2004 and has already passed its operational lifetime as identified in the device labelling two years ago. "the normal useful life of this equipment, unless otherwise stated, is ten (10) years, subject to required preventative maintenance as specified in the operating and daily maintenance instruction, the assembly and installation instructions and the spare part catalogue. " our evaluation as presented above showed that the most likely cause of the reported scalding incident was related to user error as in accordance to product's operating and daily maintenance instructions water temperature should be additionally checked by a naked hand, not only by a displayed value. If system 2000's bathing procedures were followed in accordance to instruction for use, 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 out of its specification. The device was being used for patient handling and in that way contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2016-00252 |
| MDR Report Key | 6169153 |
| Report Source | USER FACILITY |
| Date Received | 2016-12-13 |
| Date of Report | 2016-11-21 |
| Date of Event | 2016-11-18 |
| Date Facility Aware | 2016-11-21 |
| Report Date | 2017-01-11 |
| Date Reported to FDA | 2017-01-11 |
| Date Reported to Mfgr | 2017-01-11 |
| Date Mfgr Received | 2016-12-14 |
| Device Manufacturer Date | 2004-01-19 |
| Date Added to Maude | 2016-12-13 |
| 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, TX 62-052 |
| Manufacturer Country | PL |
| Manufacturer Postal | 62-052 |
| Manufacturer Phone | 2103170412 |
| Manufacturer G1 | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Street | VERKSTADSVAGEN 5 |
| Manufacturer City | ESLOV, 24121 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24121 |
| 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 GATH, INSTITUTIONAL |
| Product Code | ILM |
| Date Received | 2016-12-13 |
| Model Number | AR52101-EU |
| Operator | OTHER CAREGIVERS |
| Device Availability | Y |
| Device Age | 132 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Address | VERKSTADSVAGEN 5 ESLOV, 24121 SW 24121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2016-12-13 |