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

Model Number AJL4334-GB

Device Problems Use of Incorrect Control/Treatment Settings (1126); Maintenance Does Not Comply To Manufacturers Recommendations (2974); Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Event Description

Initially it was reported by arjohuntleigh representative that the patient was scalded during use of the bath.A client was going to get into the bath and placed his foot in the bath.He quickly called for an assistant to get him out of the bath- his foot was red and they took him to the gp who gave him antibiotics.Information provided in incident description form (idf) showed that the resident was always going into the bathroom by himself and playing with the controls so a lock was fitted to the door.

Manufacturer Narrative

(b)(4).General condition of the device has been described in incident description form (idf) as reasonable but there was a collection of debris of unknown origin under the bath, and the curtain sides at both end of the bath were rolled up.The fill buttons on the bath functioned correctly but were showing signs of age.The bath was serviced by arjohuntleigh on (b)(6) 2013 and the service label is still on the bath panel.There was no other service label evident at the time of the inspection.Mixer control panel was physically broken and the adjuster for the water temperature had come away from the mixer link rod which connects to the mixer block.The bath and shower fill still worked correctly, but the label under the controls was in a poor condition and had come away from the bath.Mixer adjuster to water temperature control was severely damaged.When reviewing similar events for malibu/sovereign (incl.Dignity) we haven't found any other similar cases.We have been able to establish that there is no complaint trend concerning these kind of events- patient scalded in malibu bath.Please note that arjohuntleigh manufactured over 13000 malibu/sovereign (incl.Dignity) baths to date.The device was inspected by an a 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.A "5 why" analysis has been performed in relation to reported incident.Our evaluation showed that the most possible root cause of this event appears to be a user error.Instruction for use (04.Aj.00/2gb from october 2004) warns: "always make sure that: the water/shower temperature is checked by hand before the bath." reported incident involves also situation where the patient was using device by itself- in accordance to product labelling this is unassisted bathing.Instruction for this cases informs: "unassisted bathing of fully independent residents should only be done after assessment and always under supervision of authorized staff." procedure for unassisted bathing warns: "fill the tub with water.Check the bath water temperature before entering the water." complained product is subject to wear and tear to preserve it safety and performance, preventive maintenance should be carried out.List of recommended steps can be found in instruction for use.Ifu (04.Aj.Oo/ 2gb from october 2004) informs that the caregiver is obliged to: check mechanical attachments every week ("check that all screws and nuts are tightened and that there are no gaps") "perform functionality test every week ("test all panel functions") " exercise the thermostat mixer every month ("tum the temperature control back and forth over the whole temperature range with water on.This is particularly important in areas with hard water.") if any parts would be found damaged or not functioning correctly, it should be replaced and device not used with the patients.Information included in incident description form showed also that the customer was aware about failure of controls: "staff claimed the mixer adjuster had been broken for approximately one month but could not be certain about the time period." we have not been able to find any contributing manufacturing anomalies from above findings we conclude that this incident was caused by user error- water temperature was not checked before use and device was not maintained correctly as recommended in instruction for use (ifu).The received information and our evaluation as described above are showing that if malibu's warnings were followed in accordance to ifu, there would be no patient or caregiver at risk.Imp.(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: 4073056
• MDR Text Key: 4827045
• Report Number: 9611530-2014-00055
• 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: Notification
• Type of Report: Initial
• Report Date: 08/05/2014,07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: AJL4334-GB
• 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: 08/05/2014
• Distributor Facility Aware Date: 07/10/2014
• Device Age: 9 NA
• Event Location: Nursing Home
• Date Report to Manufacturer: 08/05/2014
• Date Manufacturer Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2005
• 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