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

Model Number AZR23110-GB

Device Problems Component Falling (1105); Detachment of Device or Device Component (2907)

Patient Problems Bruise/Contusion (1754); Fall (1848); Head Injury (1879)

Event Date 08/11/2014

Event Type  malfunction  

Event Description

Initially it was reported by arjohuntleigh representative that a seat detached from the lifting unit while lowering the patient.Two carers were bathing a resident.They had raised the resident up out of the water and dried her off, leaving the towel wrapped around the patient.They then swung the patient over the side of the bath and started to lower her.One caregiver was on the left side ready to attach the sub chassis to the chair frame, the second caregiver was on the right side operating the handset.The sub chassis was on the floor and caregiver was directing second one on how low to lower the seat.It was noticed that the chair was lowered too far, and the caregiver told the other caregiver to raise it back up a bit.It was unsure what happened after that, but without touching the lifting arm chair catch, the chair shot off the arm at an angle towards the right.The chair ended up on the floor with the resident still in it.As a result of this incident the resident sustained bruising to the forehead.The resident was checked over by home nurse, also the residents general practitioner was informed.The resident was not hospitalized.Device examination showed that the bath was in good condition.No fault found that could have caused this to occur.The equipment - met its specification.It was not possible to recreate this event.

Manufacturer Narrative

(b)(4).Additional information will be provided upon completion of the manufacturer's investigation.(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: 4114201
• MDR Text Key: 16450633
• Report Number: 9611530-2014-00068
• 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
• Type of Report: Initial
• Report Date: 09/02/2014,08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AZR23110-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: 09/02/2014
• Distributor Facility Aware Date: 08/11/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/02/2014
• Date Manufacturer Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• 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 Age: 78 YR
• Patient Weight: 67