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

Model Number AZL23110-GB

Device Problems Unstable (1667); Device Dislodged or Dislocated (2923); Installation-Related Problem (2965)

Patient Problems Pain (1994); Injury (2348)

Event Date 11/28/2014

Event Type  malfunction  

Event Description

Initially it was reported by arjohuntleigh representative that malibu bath was tipping during use.Following a bathing procedure the patient was on the seat being removed from the bath.At the top of the seat stroke, the chair was swung 90 degrees before lowering.At this point the bath began to tip from the opposite side to the seat.The care staff reacted swiftly and stopped the downward motion of the seat and managed to counterbalance the bath back to the original position.From received information 2 carers suffered shoulder and rib injuries.On (b)(6) 2014 additional information was provided regarding outcomes to both caregivers."two of the carers have shoulder and rib injuries (the facility do not know any more than that currently).The injury regarding the broken rib is that 'it is suspected as broken although not confirmed.' no x-rays of the injury have been required." device examination included in incident description form (idf) showed that device overall condition was good.Function test showed that the bath functions correctly, however it was found by a service technician that the bath had been incorrectly secured to the floor, pictures forwarded, the fixing were insufficient to secure the bath to the floor.This issue caused the incident to occur.Incident report memo created during receiving information from the customer about incident, showed that "two malibu mk4 baths have been re-installed by a 3rd party within the last month or so (.).At this time both of the re-installed malibu mk4 baths have been taken out of use (.).".

Manufacturer Narrative

(b)(4).Please note that previous medwatch reports for this product may have been submitted for the manufacturing site arjo (b)(4).As of 2014 that number was de-activated due to the site no longer shipping product to the usa.From 2014 and going forward complaints related to these products are to be handled by arjohuntleigh (b)(4)'s complaint handling establishment.An investigation was carried out into this complaint.When reviewing the reportable events for malibu/sovereign we have been able to find few similar cases.Arjohuntleigh manufactured over (b)(4) malibu/sovereign baths to date.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 representative at the customer site and found to be out of the specification - bath wasn't correctly installed to the floor.The device was being used for patient handling and in that way contributed to the event.Arjohuntleigh representative who examined the device confirmed that "the fixing were insufficient to secure the bath to the floor.This issue caused the incident to occur." corresponding photos confirmed this failure - 2 not secured screws and no floor fixtures.The cause of the above issue can be related to the previous re-installation of a bath as stated in incident report memo: "malibu mk4 baths have been re-installed by a 3rd party within the last month or so." from above findings we conclude that this incident was caused by an user error: not following recommendation included in instruction for use regarding device preparation, installation error - bath wasn't correctly installed, and should not be used with patients.The received information and our evaluation as described above are showing that if malibu's installation requirement were followed in accordance to instruction for use, there would be no patient or caregiver at risk.

• 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: 4384094
• MDR Text Key: 5292041
• Report Number: 3007420694-2014-00148
• 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: 12/01/2014

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: Other
• Device Model Number: AZL23110-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: 12/23/2014
• Distributor Facility Aware Date: 12/01/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/23/2014
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2012
• 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
• Patient Weight: 98