MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for system 2000 we haven't' found any other similar cases.We have been able to establish that there is no complaint trend concerning these kind of events - smoke from the unit.Please note that arjohuntleigh manufactured over (b)(4) system 2000 baths to date.The device was inspected by an arjohuntleigh representative at the customer site and found to be out of the specification.The device was being used for patient handling and in that way contributed to the event.No injury to the patient occurred - patient was observed overnight and taken to the doctor next day but no lasting effects.Instruction for use (ifu) is attached with each device.Rec'd info showed that the patient was left alone when the event occurred, and he noticed smoke coming from the device when he entered the room.After that, he helped the patient get out of the tub.Our investigation shows that although there was smoke from a failing capacitor, there has been no fire nor fire risk.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 were not able to establish the exact root cause of reported malfunction.We can consider that this problem could be related to poor maintenance as no info of last service was provided and signs of wear of hydromassage pump are visible.It can be also stated that when the event occurred, caregiver not followed recommendation from instruction for use regarding supervision of the patient during use.We have not been able to find any contributing manufacturing anomalies.

• Brand Name: SYSTEM 2000
• 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: 3964765
• MDR Text Key: 20106869
• Report Number: 9611530-2014-00041
• 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: 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: 06/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 05/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2005
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1