MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB MALIBU; ILM

Model Number AZL23110-GB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bruise/Contusion (1754)

Event Date 08/15/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing reportable events for (b)(6), we have found limited number of other cases where the chair was not securely attached to the lifting arm.We have been able to establish that there is no complaint trend concerning this kind of events.Arjohuntleigh received customer complaint where it was reported that the resident had a bath several days before and two days later she claimed that she was injured by the bath lift arm dropping.The injury was described as bruising to the right hand side lower ribs, consulted with general practitioner.No treatment was applied.The nurses who were assisting the resident with that bathing session at the time were not aware of the chair lift dropping at any stage, also during and after the bathing session the resident did not mention or show any signs of discomfort or injury.It was confirmed that the resident was not left unattended at any time.Arjohuntleigh representative who performed device examination confirmed that the device was up to manufacturer specification.No repair or adjustment has been done.Product instruction for use, which is delivered with each device, includes information how to properly and safely use the device.It also includes warnings concerning the locking mechanism of the lifting unit, seat and transferring chair.From the interview it seems that all the guides and warnings included in the instruction for use were followed.What is worth to mention, "lift arm dropping", as claimed by the user, is very serious fault of this bath, and would be definitely noticed.More probable scenario of events (observed also in the previous complaints for malibu) would be detaching of the lift chair and patient's fall - however this was not confirmed by the staff assisting the bather.Arjohuntleigh representative, who went to the facility to gather all the information, discussed this matter with estate manager.They came to suspicion that the injuries were sustained elsewhere.In conclusion, no malfunction of the bath was found.It was used for patient's care and this way contributed to alleged event.Having that contradictory information we cannot confirm the event occurrence, establish exact scenario of events or root cause of the injury.Shall any additional information become available in the future, the investigation will be updated.

Event Description

Arjohuntleigh received customer complaint where it was reported that the resident had a bath several days before and two days later she claimed that she was injured by the bath lift arm dropping.The injury was described as bruising to the right hand side lower ribs, consulted with general practitioner.No treatment was applied.The nurses who were assisting the resident with that bathing session at the time were not aware of the chair lift dropping at any stage, also during and after the bathing session the resident did not mention or show any signs of discomfort or injury.It was confirmed that the resident was not left unattended at any time.

• Brand Name: MALIBU
• Type of Device: ILM
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov, 24121 ; SW 24121
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2103170412
• MDR Report Key: 5955442
• MDR Text Key: 54895317
• Report Number: 3007420694-2016-00196
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2016,08/17/2016

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: Nurse
• 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: 09/16/2016
• Distributor Facility Aware Date: 08/17/2016
• Device Age: 6 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/16/2016
• Initial Date Manufacturer Received: 08/17/2016
• Initial Date FDA Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2010
• 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: 118