MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000

Model Number AR*

Device Problems Leak/Splash (1354); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

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".

Manufacturer Narrative

(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).

• Brand Name: SYSTEM 2000
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4570313
• MDR Text Key: 5478857
• Report Number: 3007420694-2015-00050
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/02/2015,02/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR*
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2015
• Distributor Facility Aware Date: 02/04/2015
• Event Location: Nursing Home
• Date Report to Manufacturer: 03/03/2015
• Date Manufacturer Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other