MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000

Model Number AR

Device Problems Use of Device Problem (1670); Human Factors Issue (2948); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2014

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).When receiving similar reportable events for system 2000 we have similar cases.We have been able to establish that there is a very low complaint rate relating to this kind of event-tub was tipping during use.With the amount of sold devices (arjohuntleigh manufactured over (b)(4) system 2000 baths to date) and in comparison to the daily use of them the ratio observed for complaints with this failure mode is considered to be very low and acceptable.The device was inspected by an arjohuntleigh rep at the customer site and found to be out of specification- base cover off, however, this failure couldn't contribute to reported incident.The device was being used for patient handling and in that way contributed to the event.No injury to the patient occurred.Patient was positioned on hygienic chair.Please note also that info provided by arjohuntleigh rep that contacted and visited the customer site showed that it was not possible to re-create this event and possibility of this event was called into question.From the above findings we come to conclude that this incident was caused by user error- user didn't follow recommended device handling procedures and warnings included in instructions for use.It is not likely that tube would have tipped if recommended procedures included in operation and product care instructions were followed, as proved by our test reports.We have not been able to find any contributing mfg anomalies.

• Brand Name: SYSTEM 2000
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov ; SW
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov Q ; SW Q
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3799186
• MDR Text Key: 4365971
• Report Number: 9611530-2014-00029
• 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: 04/01/2014

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?: 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: 04/29/2014
• Distributor Facility Aware Date: 04/01/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/29/2014
• Initial Date Manufacturer Received: 04/01/2014
• Initial Date FDA Received: 04/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2005
• 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