MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000

Device Problems Biofilm coating in Device (1062); Microbial Contamination of Device (2303); Environmental Compatibility Problem (2929)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Imp - (b)(4).

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for system 2000 and other baths, we have low number of other cases with similar fault description (legionella issue or bacteria indication).We have been able to establish that there is a very low baseline complaint trend concerning legionella issue in baths recorded under brand name: system 2000.Please note that arjohuntleigh manufactured about (b)(4) baths to date.With the amount of sold devices and with comparison to the daily use of them the trend observed for complaints with this failure mode is considered to be acceptable.The device was inspected by an arjohuntleigh representative at the customer site and found to be to the specification.The device was being used for patient handling and in that way contributed to the event.Water supply requirements are included in the operating and daily maintenance instructions (04.Ar.08_2 gb from march 2000)" cold water temperature 2-25 degrees c (36-77 degrees f), warm water temperature 38-80 degrees c (100-175 degrees f), cold water temperature (uk models) 5-20 degrees c, warm water temperature (uk models) 52-65 degrees c.The operating and daily maintenance instructions (04.Ar.08_2 gb from march 2000) provide also information about maintenance of the device: every day care giver is obliged to clean the used device.If the recommendations in the instruction for use and assembly and installation manual are followed and the hot and cold water temperature is under control it is unlikely for legionella to be found in the bath.We have not been able to find any contributing manufacturing anomalies.From this we conclude that this incident was caused as a result of staff incorrectly or not following procedures as indicated in the instructions for use of the device.As the received information and our evaluation as described above are showing that if water supply recommendations and preventive maintenance have been correctly performed there will be no patient or caregiver risk.

• 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 ; 2103170412
• MDR Report Key: 3952634
• MDR Text Key: 4643032
• Report Number: 9611530-2014-00048
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 06/16/2014
• Initial Date FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2002
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1