MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB MALIBU/SOVEREIGN (INCL. DIGNITY)

Device Problems Device Tipped Over (2589); Installation-Related Problem (2965); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/19/2014

Event Type  malfunction  

Event Description

Initially, it was reported by arjohuntleigh rep that tub was tipping during use.Caregiver was lifting a pt on the chair attached to the sovereign, the bath was full of water, as she lifted the pt, the bath slowly started to tip sideways.The caregiver countered the tip by putting her weight on the opposite side of the bath and continued with bathing the pt.No injury occurred to the pt or caregiver as a result of this incident.Device examination showed that this is very old bath - showing signs of age, but still in working condition.It was found wood screws holding bath to floor ) floor fixing) had worked lose.Please noted that this device was in use for about 18 years.On (b)(4) 2014, additional info has been received: "the bath is secured to the floor with wood screws.The bath configuration is that it is at the wall.Floor brackets are not fitted to this bath.The wood screws used go directly through the baths feet and into the floor boards underneath.A visual inspection of the feet is taken during each visit and the bath is also loler inspected.Following the incident it has been found that the floor boards underneath the bath (that are not visible as there is a floor covering) appear to show signs of dry rot.The customer has been advised to repair and replace the wooden floor underneath the bath.".

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for malibu/sovereign, we have found a limited number of other similar cases.We have been able to establish that there is a slightly increasing but still very low complaint trend that concerns these events.(b)(4).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 rep at the customer site and found to be out of the spec - loose wood screws holding bath to floor.The device was being used for pt handling and in that way contributed to the event.Arjohuntleigh rep informed in incident description form (idf) that wood screws holding bath to floor worked loose.Provided photos showed also that some screws were removed.On (b)(4) 2014, additional info was provided by the originator of this complaint about possible root cause of this incident - "floor boards underneath the bath (that are not visible as there is a floor covering) appear to show signs of dry rot", also floor brackets were not fitted to this bath.Details regarding bath installation are included in operating product instruction (opi).Opi (1196a0062 from december 1996 - initial issue) informs: "it is important that a firm fixing is obtained at all points during the installation.Fixing screws and rawl plugs supplied with the bath will normally suit the majority of site conditions." "where a bath is to be fitted into a corner a floor bracket is provided to secure the corner foot of the bath to the floor.Where a bath is to be fitted into an alcove two floor brackets are provided to secure the two rear feet of the bath to the floor.In both cases the floor bracket(s) should be positioned and secured to the floor using the screws and rawl plugs before the bath is placed in position." please note that this device was in use for about 18 years.From above findings we conclude that this incident was caused by a combination of: installation error - not correctly installed - lack of bracket and no rawl plugs as recommended in operating product instruction; poor floor condition in customer's bathroom: "signs of dry rot." worn out equipment - device in use for about 18 years.The received info and our eval as described above are showing that if sovereign's installation requirement were followed in accordance to operating product instruction, there would be no pt or caregiver at risk.(b)(4).

• Brand Name: MALIBU/SOVEREIGN (INCL. DIGNITY)
• 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: 4180398
• MDR Text Key: 5162040
• Report Number: 9611530-2014-00080
• Device Sequence Number: 1
• Product Code: ILM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/19/2014

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: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/19/2014
• Event Location: Nursing Home
• Initial Date Manufacturer Received: 09/19/2014
• Initial Date FDA Received: 10/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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