MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2015-03-03 for SYSTEM 2000 AR* manufactured by Arjo Hospital Equipment Ab.
[5478857]
Initially it was reported by arjohuntleigh's representative that caregiver slipped outside of the bath. "after hours, caregiver went to tub room to retrieve some items. Tub was not in use. Caregiver slipped on pool of water that was leaking (from the grey shower handle per the staff member)". As a result of this incident caregiver sustained bruised leg and hip. Device examination showed that the device "was in great working order, with no issue of any operational issues. No dents or peeling of paints. Complete function test showed tub to be responding with no issues".
Patient Sequence No: 1, Text Type: D, B5
[13072620]
(b)(4). An investigation was carried out into this complaint. When reviewing similar reportable events on system 2000 baths we haven't found any other similar case. Therefore we consider this event to be an isolated incident. The device was inspected by an arjohuntleigh representative at the customer site and found to be working to its specification. However from further examination and information provided by the customer it was found that the user loosened bottom hose connection with hand pressure, what could lead to the leakage. Therefore we can state that the involved device failed to meet its specification. The device wasn't being used for patient handling, however reported malfunction contributed to the event - caregiver slipped. A "5 why" analysis has been performed in relation to reported incident. We came to a conclusion that the reported problem - caregiver slipped because of wet floor, is the most likely related to user error. Product instruction for use (ifu) is equipped with each device. Ifu (04. Ar. 08/7gb from october 2006) provides information about correct and safe use of the product. It informs: a service routine must be done on your bath system every year by arjo authorised service personnel to ensure the safety and operating procedures of your product. See chapter preventive maintenance schedule. If you require further information, please contact your local arjo representative who can offer comprehensive support and service program to maximise the long-term safety, reliability and value of the product. Contact your local arjo representative for replacement parts. Your service representative stocks the parts you will need". "if the product does not work as intended, immediately contact your local arjo representative for support". Ifu notify also: "modifications made to the equipment without express acknowledgement from arjo will invalidate supplier's product liability" instruction for use provides also information about preventive maintenance actions. In accordance to it customer is obliged to check visually hoses, pipes and connections every week - inspect for leaks of any kind. From above labelling excerpts we can state that the user did not follow ifu's recommendations. No dates or information about training to caregiver were provided. Additionally, the service technician who interviewed the customer indicated to staff member that at any time they may have any issue to contact arjo immediately and open a service call please note also that slippage is a sudden or involuntary movement where the person loses foothold, as on a smooth surface. The leakage of the water doesn't cause it by itself, but these kind of events are considered to be unfortunate accidents. There are also other factors that need to appear to cause this incident e. G. : lack of carefulness, smooth or soapy surface. Problem described in complaint (b)(4)concerns situation where the caregiver was aware about problem with leaking hose, however he didn't took precautions to solve the issue. Therefore, we also consider this event to be isolated incident where user wasn't care enough to avoid this incident. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007420694-2015-00050 |
| MDR Report Key | 4570313 |
| Report Source | 01,06,07 |
| Date Received | 2015-03-03 |
| Date of Report | 2015-02-04 |
| Date of Event | 2015-02-03 |
| Date Facility Aware | 2015-02-04 |
| Report Date | 2015-03-02 |
| Date Reported to FDA | 2015-03-02 |
| Date Reported to Mfgr | 2015-03-03 |
| Date Mfgr Received | 2015-02-04 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2015-05-07 |
| 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 | ARJO HOSPITAL EQUIPMENT AB |
| Manufacturer Street | VERKSTADSVAGEN 5 |
| Manufacturer City | ESLOV 24121 |
| Manufacturer Country | SW |
| Manufacturer Postal Code | 24121 |
| 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 | 2015-03-03 |
| Model Number | AR* |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2015-03-03 |