MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB FREEDOM BATH

Device Problems Leak/Splash (1354); Device Operational Issue (2914)

Patient Problems Fall (1848); Pain (1994)

Event Type  malfunction  

Event Description

Importer report #: (b)(4).

Manufacturer Narrative

(b)(4).When reviewing similar reportable events freedom bath we haven't found any other similar cases.There is no complaint trend concerning these kind of events.Please note that arjohuntleigh manufactured about (b)(4) freedom baths to date.The device was inspected by an arjohuntleigh representative at the customer site and found to be out of the specification - air leakage from seal was reported, but in accordance to service technician it is not likely that it could cause reported problem.The device was being used for patient handling and in that way contributed to the event.A "5 why" analysis has been performed in relation to reported incident.Regarding this analysis we are not able to establish the exact root cause of this event as in accordance to info provided by technician, no fault was found that could cause this failure.We can only assume in relation to provided service records that this device wasn't repaired correctly and the customer used it despite incorrect functionality (reported issues with device).Additionally slippage is a suddenly or involuntarily movement where the person in question loses foothold, as on a smooth surface.The leakage of the water doesn't cause it by itself, these kind of events we consider to be unfortunate accidents.In particular in bathing areas.There are also other factors that need to appear to cause this incident e.G.: lack of carefulness, smooth surface.The problem described the complaint investigated here concerns a situation where the caregiver noticed water on the floor, however, she didn't take precautions to prevent from spillage.Therefore, we consider this event to be isolated incident where user wasn't careful enough to take reasonable steps to avoid this incident.In addition to above analysis, the in-depth analysis of documentation provided with device has been reviewed.Product instructions for use (ifu) is provided with each device.Ifu (04.Af.02_6us,ca from december 2011) informs that: "the equipment must only be used for the purposes stated above, and must be installed according to the assembly and installation instructions, which can only be superseded by local code." if during preventive maintenance some parts would have been found damaged or defective, especially parts that are essential for safety, they should be replaced or repaired.In that case device shouldn't be used because safety of the product is neglected.We have not been able to find any contributing manufacturing anomalies.

• Brand Name: FREEDOM BATH
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5, box 61; eslov ; SW
• 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: 3964761
• MDR Text Key: 4605557
• Report Number: 9611530-2014-00039
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Remedial Action: Notification
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2012
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1