MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000

Model Number AR

Device Problems Device Tipped Over (2589); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for system 2000 we have found a very low number of other similar cases - tub tipped.We have been able to establish that there is no complaint trend concerning these kind of events.(b)(4).The device was inspected by an arjohuntleigh representative at the customer site and found to be to the specification - no fault was found that could cause this failure.The device was being used for patient handling and in that way contributed to the event.From received information no injury occurred to the patient as a result of this incident.The patient was secured in a sling attached to a ceiling lift.Device examination performed by a service technician showed that there was no failure that could contribute to this incident.It was also not possible to re-create this event.Additionally received information showed that user error couldn't be ruled out as there was a suggestion made by the arjohuntleigh representative, that the resident's chair was at the end of the bath and while lowering the bath the arm of the chair caught the end of the tub.The residents chair was a large size with padding so it would not leave a mark.There was no damage to the tub shell.From above findings and previously performed tests (equilibrium calculation) we conclude that this incident is related to user error - not following warnings included in instruction for use.The received information and our evaluation as described above are showing that if system 2000's warning were followed in accordance to product documentation, there would be no patient or caregiver at risk.

Event Description

It was initially reported by company representative that tub tipped during use with the patient.When the staff were lowering the tub and draining post bathing, the end of the tub was lifted up with all the weight down at the end where the control panel is.Legs were lifted off the floor and underneath the side of the tub.The resident was attached to the passive mechanical lift.From received information no injury occurred to the patient as a result of this incident.The patient was secured in a sling attached to a ceiling lift.Device examination described in incident description form (idf) showed that involved bath is in good condition, no fault was found - device met its specification.On (b)(6) 2014 a service technician provided additional information regarding this incident: it was not possible to re-create the event.The legs were lifting off towards the end of the tub, so the panel stayed on the ground and the keyshaped end lifted up.This occurred as they were lowering the tub.I feel it was an error, that staff would not admit to, that the residents chair was at the end of the bath and while lowering the bath the arm of the chair caught the end of the but, not allowing it to lower, once they noticed it they raised the tub up and removed the chair.The residents chairs is a large one with padding so it would not leave a mark.There was not damage to the tub shell or chair.My instructions to the doc, was to make all staff aware of when raising or lowering inspect the area before proceeding to move the tub up or down.Any moving up or down should be done with care and nothing within 18 inches of the tub shell, a chair, alenti etc.

• 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 ; 2102787040
• MDR Report Key: 4309301
• MDR Text Key: 19371340
• Report Number: 3007420694-2014-00113
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/26/2014,11/04/2014

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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/26/2014
• Distributor Facility Aware Date: 11/04/2014
• Device Age: 10 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 11/26/2014
• Initial Date Manufacturer Received: 11/04/2014
• Initial Date FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2004
• 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