MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SYSTEM 2000

Model Number AR33212-US

Device Problems Break (1069); Device Tipped Over (2589); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Pain (1994)

Event Date 09/04/2014

Event Type  malfunction  

Event Description

It was initially reported by the company representative that the tub tipped during use with the patient.The staff member was bathing a resident in the ceiling lift.As she was standing at the panel and pushing the up button to start to raise the tub up to working height, without any notice the bathing system started to tip towards her.As it was tipping she tried to hold it up and call for assistance.As the tub tipped to the right, the water started pouring out onto the floor.The resident was supported by a sling attached to the ceiling lift and stayed suspended in the air.From the information received, no injury occurred to the patient as a result of this incident.The caregiver did sustain a strain to the shoulder, lower back and the right leg had a small red mark.The caregiver was sent to the emergency department for evaluation.On (b)(6) 2014, the service technician reported that there were no serious injuries to the caregiver.The caregiver was cleared for regular duties.The device examination described in the incident description form (idf) showed that the bolt became loose over time and with the weight of the water in the bath causing the bolt to shear off of the back of the panel.There was still a piece of the bolt in the panel.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reporting events for system 2000 we have found a low number of other similar cases - tub tipped and bolts were found to be loose.We have been able to establish that there is no complaint trend concerning these kind of events.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.From received information no injury occurred to the patient as a result of this incident.Injury occurred to the caregiver - strain to shoulder, lower back and a small red mark to the right leg.The root cause of this event appears to be a lack or poor maintenance.Information provided by arjohuntleigh representative in incident description form (idf) shows that this event is related to the issue of cpa (b)(4)-loose leg bolts.In accordance to capa's investigation, the root cause of this problem is a combination of: installation error- bolts not correctly tightened during installation - not following recommendation in assembly and installation manual - not carrying out the maintenance in according to preventive maintenance schedule (pms).Review of other similar complaints concerning loose bolts and investigation for corrective and preventive action - (b)(4), showed that the root causes for these kind of events are: incorrect installation, not related to complaint (b)(4) because involved device was in use for about 13 years and there is no indication that this bath was re-installed by the customer, poor maintenance, not following recommendations included in instruction for use.That is related to reported event due to information provided by arjohuntleigh representative (equipment consultant), that bolts became loose and it "led" sheared off one of the bolts.Date of last maintenance was not provided.As a result of (b)(4) was released to inform about this problem and remind of checking and tightening torques.An inquiry regarding above tan has been sent to the service technician on (b)(4) 2014, however no response was provided after few reminders.From above findings we conclude that this incident was caused by user error, poor or lack of maintenance.The received information and our evaluation as described above are showing that if system 2000's preventive maintenance was followed in accordance to product documentation, there would be no patient or caregiver at risk.(b)(4).

• Brand Name: SYSTEM 2000
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5, box 61; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5,; eslov ; SW
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste. 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4147738
• MDR Text Key: 4767834
• Report Number: 9611530-2014-00076
• 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: Repair
• Type of Report: Initial
• Report Date: 09/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AR33212-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/04/2014
• Event Location: Nursing Home
• Date Manufacturer Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2001
• 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