MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000

Device Problems Device Maintenance Issue (1379); Chemical Spillage (2894); Device Operational Issue (2914)

Patient Problems Irritation (1941); Sore Throat (2396)

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).When reviewing similar reportable events for system 2000, we have found a number of other similar cases.We have been able to establish that there is an increasing but very low complaint trend concerning these kind of events - leakage of disinfectant into the bath.Arjohuntleigh manufactured over (b)(4) system 2000 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 very low and acceptable.The device was inspected by an arjohuntleigh representative at the customer site and found to be out to the specification.The device was being used for pt handling and in that way contributed to the event.From the information received both caregiver and resident were red in the throat, and irritation in throat occurred from inhaling the disinfectant.The test was performed on site at the arjohuntleigh manufacturing site in (b)(6), in relation to this kind of events, and showed that a faulty injector in combination with a malfunctioning non-return valve can cause a siphon effect making it possible for disinfectant to leak into the bath.The test also showed that the leakage is highly noticeable by smell.A worst case scenario testing has concluded a maximum mixing ratio of disinfectant that can end up in the bath during a bath session with a pt present.This mixing ratio is considered as not being likely to cause any serious injury or death.Complained bath wasn't update in accordance to recommendations provided by (b)(4), even if model number informs that this device is equipped with automatic disinfection.Technical solution introduced by this (b)(4), makes leakage of disinfectant into the tub impossible.From above findings we conclude that this incident was caused by combination of user error: not following recommendation of instructions for use (confirmed by internal test): cleaning and disinfecting the tub, and incorrect (or lack) of maintenance - parts weren't replaced and device wasn't updated in accordance to introduced (b)(4).Please note that this device was in use for about 5 years.We have not been able to find any contributing manufacturing anomalies.

• 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 ; 2102787000
• MDR Report Key: 3764867
• MDR Text Key: 16223351
• Report Number: 9611530-2014-00006
• 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: Repair
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 01/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2008
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1