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

Model Number 330

Device Problems Maintenance Does Not Comply To Manufacturers Recommendations (2974); Unintended Movement (3026)

Patient Problems Pain (1994); Tingling (2171)

Event Date 07/31/2014

Event Type  malfunction  

Event Description

Initially it was reported by arjohuntleigh representative that as a client was coming out of the bath, the caregiver raised the chair to the max.Height to allow the bath chair to swing out over the bath.On trying to lower the chair after this movement was complete, the chair suddenly dropped catching caregiver's arm causing an injury, she removed her self from this situation and another care staff arrived to finish the movement and take the client out of the bathroom.From received information caregiver had a sensation of pins and needles in her arm which possibly could mean an inflamed nerve, at the time of interview she had been taken to hospital.No other information about outcomes were provided.Device examination included in incident description form (idf) showed that involved bath has air in the hydraulic system causing this issue - uncommanded down movement.Function test confirmed that sovereign continues to bounce or jerk sporadically due to air in the system.Last maintenance was performed in (b)(4) 2014.Arjohuntleigh representative informed also that above described problem was explained to staff back in (b)(6) if this fault re-occurred to be observed and remove from use.In service technician's opinion, this bath should never had been used.

Manufacturer Narrative

(b)(4).When reviewing similar events for malibu/sovereign (incl.Dignity) we haven't found any other similar cases - bath seat lowered uncommanded with a patient on it.We have been able to establish that there is no complaint trend concerning these kind of events.(b)(4).The device was inspected by arjohuntleigh representative at the customer site and found to be out of specification - air in the hydraulic system.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.Above problem is known to the manufacturer.On 2004-11-04 technical advice notice was published regarding "falling" tendency of hydraulic seat ram (including sovereign models 310/320/330.) rams returned from the field did not show any mechanically faults and we have come to the conclusion that air in the hydraulic system causes the problem.To solve this problem, the air "bleeding" procedure has been provided with an updated technical information file.During maintenance in june 2014 service technician informed a customer about this problem and explained to monitor it, and if it re-occur remove device from use.Product instruction for use is attached with each device.From above we can conclude that this incident was caused by a combination of: user error - customer was aware about problem and used device anyway for patient handling.Service error - problem was not solved during last maintenance in accordance to the technical information available.

• 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: 4114217
• MDR Text Key: 4941041
• Report Number: 9611530-2014-00065
• 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: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 330
• 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: 08/22/2014
• Distributor Facility Aware Date: 07/31/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 08/22/2014
• Initial Date Manufacturer Received: 07/31/2014
• Initial Date FDA Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2002
• 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